Abstract: INTRODUCTION: The challenge in the field of sexual medicine is to develop evidence-based principles for clinical evaluation and create a uniform, widely accepted diagnostic and treatment approach for all sexual problems and dysfunctions, for both genders. AIM: To provide recommendations for the broad approach for assessing sexual problems in a medical practice setting; to develop an evidence-based diagnostic and treatment algorithm for men and women with sexual dysfunctions. METHODS: The PubMed literature was reviewed. Expert opinion was based on the grading of evidence-based medical literature and the Delphi consensus process. RESULTS: The Committee determined three principles for clinical evaluation and management: (i) adoption of a patient-centered framework, with emphasis on cultural competence in clinical practice; (ii) application of evidence-based medicine in diagnostic and treatment planning; (iii) use of a unified management approach in evaluating and treating sexual problems in both men and women. The International Consultation in Sexual Medicine-5 stepwise diagnostic and treatment algorithm was developed for that purpose. According to this algorithm, sexual, medical, and psychosocial history is mandatory, whereas physical examination and laboratory tests are highly recommended in most cases. Furthermore, the Brief Sexual Symptom Checklist (BSSC) for Men and BSSC for Women, and more recently the Sexual Complaints Screener (SCS) for Men and SCS for Women, were all endorsed for screening purposes. A classification system was also defined; clinically, sexual dysfunctions are categorized in three types according to their etiology (Type I: psychogenic; Type II: organic; Type III: mixed). Final recommendations on specialized diagnostic tests were based on level of evidence. CONCLUSIONS: A unified diagnostic and management strategy in sexual medicine, irrespective of condition and gender, would improve patients' sexual well-being. It would also lead to the development of academic curricula to provide practicing physicians across specialties with the needed skills to meet contemporary patients' needs in sexual medicine health-care delivery.
Abstract: INTRODUCTION: Health care professionals, especially nurses, through their contact with patients, play an important role in encouraging discussions about sexual concerns. Aim. To explore perceptions on sexual health issues and how these might inhibit or enhance Greek nurses' ability to incorporate sexual health assessment into everyday practice. MAIN OUTCOME MEASURES: A discussion guide was used as checklist to ensure that the basic issues would be addressed. Topics related to the areas of interest were either brought up from the participants or introduced by the moderator. METHODS: The study recruited a purposive sample of 44 Greek staff nurses (SN) attending a course leading to their professional upgrading. A qualitative research design was employed using seven focus groups. Discussions started with nurses' perceived definitions of sexual health and proceeded with open-ended questions. Transcripts were analyzed using thematic analysis based on the principles of grounded theory. RESULTS: Three central themes were identified from transcripts' thematic analysis: subjective perception of sexual health, discussing sexual problems, and educational and training needs. Participants' perceptions of sexual health centred mainly on the emotional and somatic dimensions. Regarding clinical practice, a variety of personal and contextual reasons limit nurses' willingness to talk about sexuality with patients, such as gender and age differences, familial upbringing, lack of time and privacy, and restricted perception of nursing role. All nurses stressed the need for further specialized training not only in physiology issues related to sexuality, but also most importantly in communication skills. CONCLUSIONS: Although Greek nurses acknowledge the importance of sexual health assessment, they believe that sexual history taking is not within the range of their professional tasks. Since holistic care demands sexual health assessment and intervention to be an integral part of nursing practice, it is necessary to introduce courses in their curriculum and experiential workshops addressing the multidimensionality of sexuality.
Abstract: CONTEXT: Erectile dysfunction (ED) after radical prostatectomy (RP) has a significant negative impact on a patient's health-related quality of life. Phosphodiesterase type 5 inhibitors (PDE5-Is) have recently been utilized not only as a treatment of ED in this population but also as a preventive strategy in penile rehabilitation programs. OBJECTIVE: To elucidate the pathophysiologic mechanisms of post-RP ED, to assess the need for rehabilitation following surgery, and to analyze the basic scientific evidence and clinical applications of PDE5-Is for the prevention and treatment of ED. EVIDENCE ACQUISITION: A systematic review of the literature using Medline, Cancerlit, and the Cochrane Library was conducted for the period between January 1997 and June 2008 using the keywords erectile dysfunction, radical prostatectomy, and phosphodiesterase inhibitors. Efficacy and safety of PDE5-Is in the randomized, placebo-controlled trials are evaluated in this review, and the limitations of the remaining studies are also discussed. EVIDENCE SYNTHESIS: Post-RP ED has many factors. Cavernosal nerve injury induces pro-apoptotic factors (ie, loss of smooth muscle) and pro-fibrotic factors (ie, an increase in collagen) within the corpora cavernosa. Cavernosal changes may also be attributed to poor oxygenation due to hemodynamic changes. Experimental data support the concept of cavernosal damage and suggest a protective role for daily dosage of a PDE5-I; however, similar data have not yet been replicated in humans. Penile rehabilitation programs are common in clinical practice, but there is no definitive evidence to support their use or the best treatment strategy. PDE5-Is are efficacious and safe in young patients with normal preoperative erectile function who have undergone bilateral nerve-sparing radical prostatectomy. On-demand use of a PDE5-I may be at least as efficacious as daily use. PDE5-I use in penile rehabilitation programs is not supported by rigorous level 1 evidence-based medicine. CONCLUSIONS: PDE5-Is are an efficacious and safe treatment for post-RP ED in properly selected patients. The experimental results on the protective role of daily dosages of PDE5-Is, while robust, have not been replicated in humans. With current human data, the role of a PDE5-I alone as a rehabilitation strategy is unclear and deserves further investigation.
Abstract: Erectile dysfunction (ED) has been revolutionized during the last two decades, as several treatment options are available today. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first choice treatment option for ED by most physicians and patients due to their high efficacy rates and favourable safety profiles. Despite the fact that more than 50 million ED patients have been treated successfully worldwide with PDE5i several issues remain to be addressed. Patients with severe neurologic damage, diabetes mellitus, or severe vascular disease may be resistant to PDE5i. Inappropriate instructions, lack of follow-up and lack of patient-centered care models have been identified as main reasons for "nonresponse", leading to drop-out rates of even > 50%. Preservation of corporal smooth muscle with chronic administration of PDE5i has been reported and there is a substantial body of evidence for beneficial effects of these drugs on endothelium and cardiovascular function. Finally, improvement of lower urinary symptoms after PDE5i administration has been reported and a possible role on treatment of premature ejaculation has been proposed. Many new PDE5i are candidates to enter the market in the forthcoming years. However, pharmacokinetic differences should be obvious to consider a truly better option for patients. Patients must be aware of all treatment options since no ideal treatment exists and physicians must offer personalized medicine to their patients in the future. The development and adaptation of a patient-centered care model in sexual medicine will increase efficacy and safety of current and future treatments.
Abstract: BACKGROUND: Few comparisons have been made of health care seeking behaviour for lower urinary tract symptoms (LUTS) between men and women, as well as trends across age groups. OBJECTIVE: To investigate the bother from LUTS and effect on health care seeking in both men and women of different age groups and in comparison between the two genders. DESIGN, SETTING, AND PARTICIPANTS: A representative cross section of each of 13 clinics of a general academic hospital, with equal numbers of subjects recruited in each of six design cells that were defined by age (18-40, 41-60, 61-80 yr) and gender. INTERVENTION: A 2-h in-person interview, conducted by a trained psychologist/interviewer in a clinic office. MEASUREMENTS: Severity of LUTS was measured by the International Prostate Symptom Score (IPSS). Treatment seeking was measured by a single item. A bother question was modified to assess overall bother. Impact on quality of life (QoL) was measured by the IPSS QoL question. RESULTS AND LIMITATIONS: The final study sample comprised 415 patients. More women than men reported the presence of LUTS (85.5% vs 75.2%; p=0.01). LUTS were more bothersome in women (25.4% of women vs 17.6% of men with bother "some" or "a lot"; p=0.02). Severity of LUTS increased with age in both genders (men: p<0.001; women: p=0.03). Bother from LUTS increased as severity of symptoms increased in both genders (p<0.001) but was associated with age only in men (p<0.001). QoL showed similar results as bother. Although men and women had equal prevalence of treatment seeking (27.9% vs 23.7%; p=0.40), men, but not women, were more likely to seek treatment as age (p<0.01) and severity of LUTS (p<0.001) increased. In multivariate logistic regressions, only bother from LUTS was associated with treatment seeking in women, compared with bother, age, and the presence of voiding symptoms in men. CONCLUSIONS: In our hospital-based sample, differences in LUTS frequency, bother, and health care seeking profiles between men and women suggest a different perception and response to LUTS between the two genders.
Abstract: ABSTRACT Introduction. Despite its importance for epidemiological and clinical reasons, relatively few studies investigated determinants of bother or distress associated with sexual problems. Aim. To assess perception of bother from sexual concerns and examine its role in predicting treatment-seeking. Main Outcome Measures. The Brief Sexual Symptom Checklist and two single-item questions were used to assess type of sexual problems, level of bother, and treatment-seeking behavior. Methods. Participants were recruited by selecting all sequentially eligible patients in each of the hospital's clinics. The scales used were drawn from the Hospitalized and Outpatients' Profile and Expectations Study survey instrument. Data were analyzed using chi-square, Fisher's exact tests, and multivariate logistic regression models. Results. In total 415 inpatients (48% men and 52% women) participated in the study. A high prevalence of male and female sexual problems was obtained (more than 50%) with a high degree of overlap among the various sexual problems. Common profiles included lack of desire and arousal or orgasmic problems in the women (8-9%); erectile dysfunction (ED) and low desire in the men (21.7%). Forty-five percent and 34% of our male and female participants, respectively, reported moderate or severe bother with its level declining with aging only in women (P < 0.001). Degree of bother was strongly associated with ED (P = 0.005) and curved penis (P = 0.02) in men, and with difficulties reaching orgasm (P = 0.01) in women. In both genders, bother increased the likelihood of willingness to discuss the sexual problem with a physician (odds ratio [OR] 10.66 for men and OR 4.35 for women); only in women, bother was associated with treatment seeking (OR 2.81). Conclusions. Sexual dysfunctions are not always associated with increased bother or dissatisfaction, a condition that influences treatment-seeking behavior. Such findings are of clinical importance as they aid physicians in establishing a diagnosis of a sexual disorder.
Abstract: BACKGROUND: Although many models have been developed to explain health behaviour, differences in individual response to symptoms remain largely unexplained; moreover, they tend to underestimate affective (i.e., emotional) processes and they neglect the construct of well-being, despite its predominant role in the definition of health. AIM: The development of a novel conceptual framework to explain and predict variability in individuals' responses to symptoms, through a bio-psychosocial perspective, considering also the potential role of subjective well-being. MATERIALS & METHODS: The most widely used health behaviour models were being reviewed, as well as their limitations. Based on the evidence in the literature, major domains that influence response to symptoms are identified and analysed. RESULTS: A new conceptual framework that is not limited to explanation of common health behaviours such as treatment seeking or problem identification, but draws attention to a broad spectrum of individual reactions and experiences following the physical experience of a symptom or medical condition. The role of subjective well-being and its determinants are considered as a central concept in the proposed framework. DISCUSSION: The present conceptual framework provides a comprehensive bio-psychosocial perspective on behavioural outcomes related to individual response to symptoms. CONCLUSION: The proposed framework opens a new window to patient centred care. Research to evaluate the proposed framework may improve the quality of clinical care and overall patient satisfaction.
Abstract: INTRODUCTION: Sexual health services are limited and inadequate to reduce factors that hinder treatment and adequate care, despite the growing interest for public awareness and prevention strategies. AIM: The aim of this study was to present an integrative conceptual framework, which led to the development of a model of alternative sexual health services and the 10-year experience of the practice of the service. MAIN OUTCOME MEASURES: Multiple-level needs assessments. METHODS: The conceptual framework is composed of four distinct elements: (i) it adopts a social/ecological perspective; (ii) it assumes that results are optimal when multiple interventions are used; (iii) interventions are influenced by behavioral theories; and (iv) sexual health is conceptualized through the biopsychosocial model. Based on this model, a Sexual and Reproductive Health Center was developed, dedicated to research, education, and public awareness. RESULTS: Over 10 years of experience show that the present approach constitutes a process which: (i) facilitates our understanding of the needs at individual, community, and system level; and (ii) increases the individuals', community and systems' capacity to control sexual health. CONCLUSION: Alternative models for sexual and reproductive health services should be encouraged, in order for best practices to be explored and identified. In addition, future research in the effectiveness of such interventions shall be beneficial in order for evidence-based interventions to be designed.
Abstract: OBJECTIVES: To define ultrasonographic patterns reflecting different states of Peyronie's disease (PD) and to use them to evaluate the natural history of the disease. MATERIAL AND METHODS: Diagnosis of PD was based on medical and sexual history, physical examination, intracavernosal injection test, and penile ultrasonography. Patients with penile fracture history were excluded from the study. Three groups were formed according to ultrasonographic patterns: solitary hyperechoic lesion without acoustic shadow (group A), moderately hyperechoic multiple scattered calcified lesions with acoustic shadows (group B), dense calcified hyperechoic plaque with acoustic shadow (group C). All patients entered a watchful waiting protocol for 1 yr followed by a new penile ultrasonography. RESULTS: Ninety-five 95 patients with PD were included in the study (mean age, 57.2+/-9.1 yr; mean duration of disease, 12.9+/-8.9 mo). Risk factors associated with cardiovascular disease were present in 79 of 95 patients (83.16%). Eleven (11.6%), 35 (36.8%), and 49 (51.6%) patients were classified into groups A, B and C, respectively. At the end of the study, in group A, reduction of fibrotic lesions and curvature angle was noticed in 9 of 11 (81.8%) patients, whereas plaque formation was noticed in 2 of 11 (18.2%) patients. In group B, plaque and curvature reduction was noticed in 15 of 35 (42.9%) and 12 of 35 (34.3%) respectively, whereas in the rest a dense calcified plaque was noticed. In group C, no ultrasonographic evidence of improvement was noticed; curvature angle was reduced in 4 of 49 (8.2%), owing to the extension of the plaque circumferentially. Significant hemodynamic changes were noticed at the two time points tested (30.53% diagnosed with vascular disease at baseline vs. 46.32% at the end of the study, p=0.03). CONCLUSIONS: Corporal ultrasonography in patients with PD allows objective evaluation and classification of disease. The density of echogenic areas and presence of acoustic shadows are predictors of disease stability.
Abstract: The present study aimed to investigate factors associated with sexual interest and behaviors in married older adults. The study recruited older adults from the Open Protection Centers for Elderly. A 30-items questionnaire addressing sexuality, emotional and physical intimacy, demographics, and background data was constructed. Dichotomous responses were used for intimacy and sexuality items. Data were analyzed using Chi-square tests, Pearson's correlation coefficient and Independent samples t-test. The sample consisted of 454 married participants (age range: 60-90, mean: 69.0+/-6.5). More than 50% reported having sexual desire and intercourse's average frequency of 4/month. Increasing age and marriage's years related significantly to decreased frequency of sexual intercourse (p<0.001). Participants married out of love reported higher frequency of intercourse p.a. compared with those in arranged marriages (p=0.031). Gender, age, income, married out of love and being still in love with the partner were all significantly associated with sexual interest and behaviors (p<0.05). This study demonstrates that older adults remain sexually active and a range of personal, socio-economic and interpersonal factors are associated with sexual interest. Therefore, sexual expression should be a well-informed individual's choice and not the result of societal myths or health professionals' misconceptions.
Abstract: INTRODUCTION: It has been proposed that women's sexual problems/dysfunctions, in the absence of personal and interpersonal distress, may have little clinical importance, as they may not necessarily affect women's sexual satisfaction. However, data are missing to support such interpretation. AIM: The objective of the present study was to examine whether the presence of a sexual problem necessary affects women's satisfaction with sexual function. METHOD: The study included 164 women who visited a general hospital because of symptoms not related to their sexual function and were asked to complete voluntarily and anonymously demographic data and two questionnaires. MAIN OUTCOME MEASURES: Women completed the Female Sexual Function Index (FSFI)--an instrument which evaluates women sexual function--and the Symptom Checklist of Sexual Function-women version (SCSF-w), a screening tool of women's self-perception of sexual function. RESULTS: Mean patients' age was 43 +/- 12.6 (18-72) years. According to the FSFI, 48.8% of the participants had a sexual dysfunction. However, based on their self-perception of sexual function (SCSF), 80.5% of the sample declared to be satisfied with their sexual function, despite the fact that 69.5% of them reported at least one sexual problem. Of all women, only 26.2% would like to talk about their sexual problem(s) with a doctor (57.4% of those who are "bothered" by their sexual symptoms). Logistic regression analysis revealed no association between any sexual dysfunction and women's satisfaction from their sexual function. CONCLUSION: Despite the presence of sexual problem(s), women may be satisfied with their sexual function, but half of those who are bothered would like to talk about it with their doctor. The presence of a sexual problem or its severity is not a determinant of women's help-seeking behavior. Such data strongly support current definitions of women's sexual dysfunction, where the presence of personal distress has been included as a crucial dimension.
Abstract: AIMS: Erectile dysfunction (ED) is a common comorbidity in men with diabetes mellitus. Tadalafil 10 or 20 mg taken on demand is efficacious and safe for men with diabetes and ED. Recently, continuous treatment with tadalafil has been proposed, addressing ED management as any other chronic condition. This study examined whether once-daily tadalafil 2.5 and 5 mg is efficacious for men with diabetes and ED. METHODS: This randomized, double-blind, placebo-controlled, multicentre, 12-week study enrolled 298 men with diabetes and ED to once-daily treatment with placebo, tadalafil 2.5 mg or tadalafil 5 mg. Primary efficacy measures were International Index of Erectile Function Erectile Function (IIEF EF) Domain score, and patient success rates for vaginal penetration and completion of intercourse. Patient satisfaction, endothelial function biomarkers, and safety were also assessed. RESULTS: Patients receiving either dose of tadalafil had clinically and statistically significant improvements in IIEF EF and statistically significant improvements in mean success rates for vaginal penetration, completion of intercourse, and overall treatment satisfaction (P < or = 0.005 tadalafil vs. placebo, all measures). Endothelial dysfunction biomarkers were unchanged. The most common adverse events were headache, back pain and dyspepsia. CONCLUSIONS: In this first study of men with diabetes and ED, once-daily tadalafil 2.5 and 5 mg was efficacious and well tolerated, suggesting this may be an alternative to on-demand treatment for some men, eliminating the need to plan sex within a limited timeframe.
Abstract: OBJECTIVE: To evaluate the efficacy, tolerability, and treatment satisfaction after initiating treatment with sildenafil 50 mg and later titrating to 100 mg, compared with continuing treatment with sildenafil 50 mg, in men with erectile dysfunction (ED). PATIENTS AND METHODS: A multicentre, parallel-group trial was conducted in two 4-week periods. In period 1, patients received 50-mg doses of sildenafil single-blinded for 4 weeks. In period 2, patients were randomized to double-blind, placebo-controlled treatment with sildenafil 50 mg or sildenafil 100 mg for 4 weeks. All patients were aged >or=18 years with a documented clinical diagnosis of ED (score of <or=25 on the International Index of Erectile Function, IIEF, Erectile Function, EF, domain), and met the prescribing criteria for sildenafil 50 mg and 100 mg. RESULTS: Of 492 enrolled patients (mean age 53 years, SD 11), 476 (97%) completed period 1 and 473 (96%) completed period 2. Patients receiving sildenafil 50 mg in period 1 had an increase in the mean (SD) baseline EF domain score from 12.8 (5.2) to 22.5 (6.6) (P < 0.001), and improved scores on the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX-Q). The IIEF EF domain scores were similar in the two groups at baseline and randomization. Patients titrated to the 100-mg dose (237 men) showed a significantly greater improvement than those who continued on the 50-mg dose (240; P < 0.001). There was a significant increase in QEQ and SEX-Q scores in patients titrated to sildenafil 100 mg compared with patients continuing at sildenafil 50 mg. At either sildenafil dose, headache, flushing and hot flushes were the most common adverse events. Neither the frequency nor the severity of adverse events increased with titration to sildenafil 100 mg. CONCLUSIONS: After initial treatment with sildenafil 50 mg, patients titrated to 100 mg showed further increases in efficacy and satisfaction with no increase in the number or severity of adverse events than in those remaining on the starting dose.
Abstract: Erectile dysfunction (ED) is a common condition in men with cardiovascular disease (CVD), yet it is frequently under-recognized and under-diagnosed in clinical practice. Men are often reluctant to seek treatment, even though they have lower sexual and overall life satisfaction compared with healthy people. Moreover, moderate ED has a similar impact on a patient's satisfaction with sexual life as severe ED. Both patient- and physician-related factors contribute to the under-diagnosis and under-recognition of ED. A holistic, patient-centered approach is fundamental to the management of ED in men with CVD. Sexual medical training courses can enhance physicians' communication skills. Implementing lifestyle changes, recognizing the factors that lead to poor compliance and reducing psychologic stress can also lead to improvements in the management of ED. As ED and CVD share similar risk factors, a common prevention strategy has been proposed.
Abstract: INTRODUCTION: Patients' sexual concerns are frequently underestimated because of health professionals' reluctance to address sexual health issues. Though it has been documented that sexual attitudes are extremely influential in everyday clinical practice, limited data exist on identifying health professionals' attitudes. AIM: To explore sexual attitudes in medical students and students in allied health professions. MAIN OUTCOME MEASURES: The Derogatis Sexual Functioning Inventory (DSFI)-Attitude Subscale was used to assess sexual attitudes. METHODS: The sample included 1st and 4th year college students enrolled in the following academic departments/schools of two academic institutions leading to health professions: medical school, psychology, pharmaceutical school, nursing and midwifery. Demographic data were obtained relating to sexual behaviors and information sources on sexual issues. Data were analyzed using independent samples t-test and two-way analysis of variance, as well as logistic regression and Pearson's correlation coefficient. RESULTS: A total of 714 students (81.9% females) participated in the study: 48.5% 1st year students and 51.5% seniors with a mean age of 20.17 years (SD = 1.87, range 17-25). Using iterative cluster analysis on DSFI scores, participants were divided in conservative (N = 167), liberal (N = 224), and neutral (N = 323) clusters. A significant gender difference on sexual attitudes was obtained (P < 0.001) with male students being more liberal compared to females (mean = 18.26 and mean = 11.13, respectively). Differences were also revealed for the field but not for the year of study. Analysis also revealed that liberalism in sexual attitudes is more likely to be affected by a liberal stance toward religion (OR: 2.39), receiving information for sexual matters mainly from peers (OR: 1.86), and media influence on students' sexual life (OR: 1.68). CONCLUSIONS: Gender, personal values, and experiences influence students' attitudes toward sexual issues. Since negative attitudes can impede effective sexual health consultations, it is imperative to incorporate courses on effective communication and human sexuality in the medical and allied health professions curricula that will enhance students' awareness of their own values and prejudices.
Abstract: The treatment of erectile dysfunction (ED) has been revolutionized during the last 2 decades with several treatment options now available. Most of these treatments are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice treatment option for ED by most physicians and patients. In addition, several new PDE5 inhibitors are candidates to enter the market in forthcoming years (avanafil, udenafil, SLx-2101, mirodenafil [SK3530]). However, obvious pharmacokinetic differences that result in a faster time-to-onset, longer half-life time and better safety profile are required for these drugs to be considered a truly better option for patients. Other molecules in development include selective dopamine, glutamate, serotonin and melanocortin receptor agonists, guanylate cyclase activators, rho-kinase inhibitors and hexarelin analogues, while the first trials on gene therapy and tissue engineering for reconstruction of corporal tissue are under way. Patients must be aware of all treatment options since no ideal treatment exists. It is expected that the availability of drugs with different mechanisms of action will allow physicians to offer more personalized medicine to their patients in the future. The development and adaptation of a patient-centred care model in sexual medicine will increase the efficacy and safety of current and future treatments.
Abstract: BACKGROUND: Advancements within assisted reproduction technologies (ART) raise ethical questions; however, research on health care professionals' attitudes towards their application is limited. This study aimed at assessing certified (CMs) and Student (SMs) midwives' attitudes towards various aspects of ART as well as comparing them with public opinion. METHODS: The final sample included 567 female CMs and 605 women from the general population (age range: 25-62 years), 221 SMs and 209 female non-SMs (age range: 18-24 years). The questionnaire administered included socio-demographic information, items addressing knowledge issues and attitude statements. Data were analysed using principal components analysis, one-way analysis of variance and Friedman's test, as well as multiple linear regression. RESULTS: Four attitudinal factors emerged: 'genetic counselling' (GC), 'application of ART', 'moral dilemmas' and 'socio-ethical aspects'; occupational status did not affect attitudes towards GC, however SMs expressed more positive attitudes regarding the latter three factors (P<0.001: 17.49, 14.14 and 11.55). Student groups expressed more negative attitudes for multifetal pregnancy reduction (SMs: 1.88+/-0.83; non-SMs: 2.17+/-0.77) whereas the other two groups were least favourable towards embryo donation (2.30+/-0.80, CM; 2.32+/-0.83, general population). Sex selection and the use of ART by menopausal or homosexual women were the least acceptable practices for all groups (P<0.001). A high level of relevant knowledge was positively associated with 'application of ART' and acceptability of its use by specific population groups (b=0.469, b=0.19). Findings on factors influencing attitudinal patterns are further discussed. CONCLUSIONS: In this first attempt, it was revealed that CMs express the same conservative attitudes as the general population.
Abstract: INTRODUCTION: Several complications during and after penile implantation have been reported. The most difficult part of the procedure seems to be the dilatation of the corpora, especially in fibrotic cases. AIM: To report a rare intraoperative complication during dilatation of the corpora and its management. METHODS: During dilation of the corpora cavernosa with Brooks dilators for the implantation of penile prosthesis, its head was detached and stuck at the tip of the corpus cavernosum. Several trials to remove the head of the dilator using different kinds of clamps were unsuccessful. Finally, an incision was performed to the distal lateral part of the corpora cavernosa and the head of the dilator was removed. Implantation was completed uneventfully. RESULTS: The patient instructed to inflate the prosthesis and use it for sexual intercourse after 6 weeks. Follow-up was 14 months and the patient is using properly the prosthesis. CONCLUSIONS: Although this is a very rare complication not previously described, we recommend examination of the dilators before use.
Abstract: PURPOSE: Patient-centredness should be at the heart of medical education. This longitudinal study aimed to assess possible attitude changes towards patient-centredness in a medical students' cohort as they progressed through the clinical curriculum. It also investigated the possible impact of socio-demographic factors on students' attitudes. METHODS: The same student cohort was tested on 2 occasions: during their initial exposure to clinical curricula (year 4) and after 2 years, at the end of the clerkship (year 6). Students completed a questionnaire including demographics and the 18-item Patient-Practitioner Orientation Scale (PPOS). PPOS differentiates between patient-centred versus doctor-centred or disease-centred orientation, measuring attitudes along 2 dimensions: 'sharing' and 'caring'. RESULTS: A total of 483 fully completed questionnaires was returned (response rate 83%). The cohort's attitudes were significantly more doctor-centred at the end of their studies compared to the beginning of their clinical curricula (P < 0.001). However, regarding the caring part of their relationship with patients, they maintained a satisfactory level of patient-centredness. Concerning sharing information, female students were significantly more patient-centred at year 4, with their mean score decreasing at the end of their clerkship. Furthermore, among only female students, having a looser relationship with religion was associated with more patient-centred attitudes. CONCLUSIONS: Increased authoritarianism in graduating students' attitudes emphasises clearly the need for future research and redesigning communication curricula. Furthermore, the influence of gender and relationship with religion on attitudes towards the doctor-patient relationship should be explored further, in order to eliminate disparities in the provision of patient-centred medical care.
Abstract: AIMS: Current management guidelines propose pelvic floor muscle training (PFMT) as first line treatment for female stress urinary incontinence (SUI). The aim of this study is to compare the efficacy of group PFMT under intensive supervision to that of individual home therapy in women with SUI. MATERIAL AND METHODS: Thirty women with clinical and urodynamic diagnosis of SUI were randomized in two equal-number groups. Following a common demonstration course, Group A women received a detailed schedule for home training, while Group B in addition attended a weekly hospital group visit. At 12 weeks both groups were assessed for changes in subjective and objective outcomes. RESULTS: Twenty-two women, (10 Group A, 12 Group B) with a mean age of 47.3 years completed the study. Although significant (P<0.05) improvements were noted in both groups in quality of life scores, number of incontinence episodes/week, 24-hr frequency, and endurance, repetitions and fast contractions upon vaginal assessment of the PFMs, comparative analysis at the end of the study demonstrated significantly better results for women in Group B, who also improved in daily pad usage, underwear wetting, modified Oxford grading of the PFMs and hold with cough. Consequently, significantly more women in Group B reported improvement in their continence (100% vs. 20% in Group A). CONCLUSIONS: Group PFMT under intensive supervision produced significantly better improvements in primary and secondary outcomes in the short-term compared to individual, unsupervised home application of PFMT.
Abstract: OBJECTIVES: We have investigated the effects of terazosin on the content of glycosaminoglycans (GAGs), the activity of matrix metalloproteinase 2 (MMP-2) and MMP-9, and the content of tissue inhibitors of MMP (TIMP) in the ventral prostate of Wistar rats. METHODS: Rats were treated with terazosin (0.12, 1.2mg/kg orally every second day) for 120 d. GAGs were isolated and purified from ventral prostate homogenates by lipid extraction, ethanol precipitation, and extensive digestion with pronase and DNAse, separated by electrophoresis, and characterised using specific enzymes. The activity of MMP-2 and MMP-9 was estimated using gelatin zymography and TIMP-1 and TIMP-2 were measured by enzyme-linked immunosorbent assay. RESULTS: Terazosin treatment did not affect the weight of the ventral prostate gland. The prostate contains hyaluronic acid, chondroitin sulfate (CS), dermatan sulfate (DS), and heparan sulfate (HS), MMP-2, TIMP-1, and TIMP-2, but not MMP-9. Terazosin caused a significant increase in the relative content of DS and a significant decrease in the relative content of CS and to a lesser extent of HS. Terazosin evoked a significant increase in the activity of proMMP-2 and MMP-2 but did not affect TIMP. CONCLUSIONS: The differential effect of terazosin treatment in GAG molecules of the rat prostate may be beneficial because CS is known to induce and DS to inhibit cell proliferation. The effect of terazosin on GAGs and MMP-2 may contribute in the molecular mechanisms of terazosin-induced apoptosis because HS and CS have a proapoptotic effect, whereas DS and MMP-2 are antiapoptotic.
Abstract: OBJECTIVE: Review the literature on phosphodiesterase type 5 inhibitors (PDE5-Is), addressing critical issues in their current and future use, assessing unanswered questions, and identifying research needs. METHODS: A MEDLINE search was conducted on PDE5-Is, with emphasis on clinical trials and experience, for interpretation and analysis of their present and future role. RESULTS: Although approximately 40 million patients with erectile dysfunction have been treated successfully worldwide with the three available PDE5-Is, inappropriate instructions, lack of follow-up, and lack of patient-centered care models are the main reasons for "non-response," leading to drop-out rates of >50%. Patients with severe neurologic damage, diabetes mellitus, or severe vascular disease may be resistant to PDE5-Is. Preservation of corporal smooth muscle with chronic administration of PDE5-Is has been reported and substantial evidence indicates that these drugs have beneficial effects on endothelium and cardiovascular function; sildenafil has been approved for the treatment of idiopathic pulmonary hypertension. Improvement of lower urinary tract symptoms in men with benign prostatic hyperplasia after PDE5-I administration has been also suggested. CONCLUSIONS: The data indicate the necessity for (1) exploration of the pharmacologic characteristics of the three PDE5-Is; (2) research on their pharmacologic differences because some actions seems to be drug-specific; (3) development of alternative management strategies, such as chronic, low, everyday doses of PDE5-Is, if the monthly cost is affordable; and (4) clinical trials on use of PDE5-Is to treat other chronic conditions. The door for innovative therapeutic approaches will open, specifically for cross-risk factor treatment with PDE5-Is or their use in combination treatments or new multimodal pills that take advantage of drugs that exert pleiotropic vascular actions.
Abstract: Sexual classification systems are based on precise and understandable definitions of sexual dysfunctions and are needed for investigative research, determination of diagnostic standards, and delineation of treatment strategies. The four major categories of sexual dysfunctions include disorders of sexual desire/interest, arousal, orgasm, and sexual pain. The purpose of this article is to review the major features, differences, and similarities of the six classification systems widely used in sexual medicine, including the International Classification of Diseases, the Diagnostic and Statistical Manual of Mental Disorders, the National Institute of Health Consensus Conference on Impotence, the American Foundation for Urologic Diseases, International Consensus Conference on Women's Sexual Dysfunction, and the First and Second International Consultations on Sexual Dysfunctions.
Abstract: AIMS: This report describes patterns of treatment changes with the phosphodiesterase type 5 (PDE5) inhibitors tadalafil, sildenafil and vardenafil, and variables associated with those treatment changes, during the 6-month, prospective, pan-European Erectile Dysfunction Observational Study (EDOS). METHODS: EDOS observed 8047 men > or = 18 years old with erectile dysfunction (ED), who began or changed ED therapy as part of their routine healthcare. Patients could change ED treatment at any time during EDOS. Data were collected at baseline and at 3 (+/- 1) and 6 (+/- 1) months. Analyses included ED treatment-naïve patients with complete follow-up who were prescribed a PDE5 inhibitor at baseline (n = 4026). RESULTS: Most patients, regardless of what PDE5 inhibitor they were prescribed at baseline, continued on that same PDE5 inhibitor throughout the study. Continuation rates were approximately 89% in the tadalafil cohort, vs. 63-64% in the sildenafil and vardenafil cohorts. The variables most strongly associated with increased risk of switching were prescription of sildenafil or vardenafil, vs. tadalafil, at baseline (odds ratios 4.43 and 4.14 respectively; p < 0.0001). Of patients who switched from tadalafil to another treatment, nearly 25% had switched back to tadalafil by study end. In contrast, of patients who switched from sildenafil or vardenafil, < 10% from each cohort had switched back to their original treatment by study end. CONCLUSION: The data suggest that tadalafil treatment in treatment-naïve ED patients may increase their likelihood of treatment continuation. These findings should be interpreted conservatively due to the observational nature of the study.
Abstract: OBJECTIVES: This study explored the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours before sexual intercourse. METHODS: A 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20mg) was conducted in men with ED for >6 months who failed >or=50% of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout. RESULTS: 383 patients were randomized to vardenafil (n=194) or placebo (n=189). Patients treated with vardenafil 8 hours before sexual activity achieved clinically meaningful (>or=18%) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2-10, compared with patients receiving placebo (SEP3 69% vs 34%; SEP2 81% vs 51%; both p<0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p<0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p<0.001). Vardenafil was generally well tolerated. CONCLUSIONS: The extended duration of efficacy of vardenafil up to 8 hours postdose may provide couples with more flexibility in their sexual life than anticipated.
Abstract: PURPOSE: To explore the life satisfaction of patients with erectile dysfunction (ED) and to examine the relation between severity of ED and life satisfaction. MATERIALS AND METHODS: The study sample was recruited from patients who presented in an andrologic outpatient clinic complaining of ED. All patients underwent the basic clinical evaluation and were assessed by the International Index of Erectile Dysfunction (IIEF) and the Life Satisfaction Inventory (LSI). RESULTS: The study included 69 patients with ED (age range 22-71 years, mean 49.5, SD 13.7). The LSI appeared to have satisfactory internal consistency (Cronbach's alpha = 0.82). Men with ED had significantly lower satisfaction with their sexual life (t = -13.756, d.f. = 68, P = 0.000), but also significantly lower total score of satisfaction with their life (t = -2.793, d.f. = 68, P = 0.007) compared with available normative data from healthy population. However, when compared with controls, men with ED showed significantly higher satisfaction scores on their financial status (t = 5.075, d.f. = 68, P = 0.000) and on their leisure time activities (t = 4.029, d.f. = 68, P = 0.000). Regarding ED severity, mild ED affects patients' satisfaction with sexual life less than do moderate and severe ED. Interestingly, no difference was identified between moderate and severe ED groups. CONCLUSIONS: Men who seek help for ED have lower satisfaction with sexual life and lower satisfaction with their overall life compared with healthy people. Severity of ED seems to be an important factor, as men with moderate ED perceive the impact of ED on their life satisfaction equally with those with severe ED. ED patients gain more satisfaction from other domains of their life, provided they adopt coping behaviors that help compensate for their low overall life satisfaction. Furthermore, as ED patients do not differ from healthy people in their expressed subjective rating of quality of life (QoL), life satisfaction may be more sensitive than QoL assessment in the evaluation of the impact of ED on our patients' life.
Abstract: OBJECTIVES: To develop and test step-wise treatment strategy for erectile dysfunction "non-responders" to tadalafil and vardenafil. MATERIAL AND METHODS: Two groups [tadalafil-treated (TG); vardenafil-treated (VG)] of 100 consecutive patients complaining of non-response to treatments were enrolled in three-phase study. Phase 1: inadequate use was identified and patients were rechallenged, after receiving detailed usage information. Phase 2: true non-responders were given new instructions based on drugs' pharmacologic profiles: TGs were dosed at least 2 h before intercourse; VGs were dosed only in fasted state. Remaining non-responders entered phase 3: continuous administration of 20 mg tadalafil every other day, or 20 mg vardenafil every day for 2 weeks. Efficacy was based on positive (yes) response to two questions: "Were your erections rigid, and did they last long enough to have successful intercourse?" and "Do you want to repeat your prescription?" RESULTS: Tadalafil group: Inappropriate use was recognized in 32 patients; 14 (43.75%) responded after adequate instruction. Phase 2: 32 of 86 (37.2%) had intercourse at least 2 h after dose intake. Phase 3: 6 of 86 (11.1%) responded to continuous administration. Overall salvage rate was 52 of 100 (52%). Vardenafil group: Inappropriate use was recognized in 38 patients; 12 (31.58%) responded after adequate instruction. Phase 2, 22 of 88 (25%) responded to dosing in a fasted state. Phase 3: 12 of 66 (18.2%) responded to daily dosing. Overall salvage rate was 46 of 100 (46%). CONCLUSIONS: Following proposed treatment strategy may maximize response rate to phosphodiesterase 5 inhibitors; appropriate usage instructions may play significant role in response rate.
Abstract: OBJECTIVES: Although the World Health Organization has declared that sexual health is an integral part of overall health, physicians seem to engage in taking the sexual health history less than their patients would desire. This study aimed at investigating the factors that predict physicians' involvement in addressing sexual health issues, including their attitudes toward the doctor-patient relationship, as well as sexual issues. METHODS: Physicians participating in educational courses on erectile dysfunction were the study sample, and anonymously and optionally completed a battery of questionnaires. In addition to demographics and a questionnaire on their involvement in taking sexual histories, the beliefs about the doctor-patient relationship were measured by the Patient-Practitioner Orientation Scale, while the Physician Belief Scale was used as the measurement of the psychosocial aspects of patient care. Finally, participants completed the Derogatis Sexual Functioning Inventory--Attitude subscale, in order to determine the possible role of physicians' sexual attitudes. RESULTS: Previous training in communication skills was found to be the strongest predictor for sexual history taking. Physicians addressing patients' psychosocial concerns were found to be more likely to ask for sexual health problems and to consider their management as less difficult. Other identified predictors of their involvement in sexual history taking were their medical specialty-possibly reflecting their level of education in sexual medicine--and having liberal sexual attitudes; female physicians and general practitioners reported more difficulty in dealing with sexual problems. CONCLUSIONS: Physicians' training in communication skills seems to be fundamental for sexual history taking and the management of sexual problems, as it improves their level of comfort in dealing with sexual issues; exposure to sexual medicine courses, and psychosocial orientation, as well as physicians' personal sexual attitudes, are also important factors affecting their involvement in sexual medicine.
Abstract: INTRODUCTION: Tadalafil, an inhibitor of phosphodiesterase 5 (PDE5), is indicated for treatment of erectile dysfunction. Most tadalafil clinical trials excluded patients with unsuccessful prior treatment with sildenafil citrate (sildenafil). AIM: This retrospective analysis of pooled data from 14 tadalafil clinical trials examines the effect of this exclusion by comparing efficacy results in 1,349 patients without prior sildenafil use (naïve, presumably a mixture of potential responders and nonresponders) with efficacy results in 1,440 patients previously responsive to sildenafil (prior responders). MAIN OUTCOME MEASURES: Efficacy measures included the International Index of Erectile Function (IIEF) erectile function (EF) domain, overall satisfaction (OS), and intercourse satisfaction (IS) domain scores; Sexual Encounter Profile (SEP) diary questions 2 through 5 (SEP2 [successful penetration], SEP3 [successful intercourse], SEP4 (satisfaction with hardness of erection), and SEP5 [overall satisfaction with the sexual experience]); and a Global Assessment Question (GAQ1) (13/14 trials) about erection improvement. Efficacy was compared using analysis of covariance (IIEF and SEP) and logistic regression (GAQ1) models. METHODS: After a 4-week, treatment-free, run-in period, patients in 14 double-blind, placebo-controlled, parallel-group trials were treated with tadalafil 10 mg, tadalafil 20 mg, or placebo for 12 weeks (dosed as needed before sexual activity, no more than once daily). RESULTS: Tadalafil improved erectile function compared with placebo (P < 0.001) in naïve patients and sildenafil prior responders for all efficacy measures. For most efficacy outcomes, responses in the naïve group (probable mix of responders and nonresponders) were not statistically different from responses in the prior-responder group (P >or= 0.10). CONCLUSIONS: The similar responses of these two patient groups observed in this post hoc analysis suggest, but do not confirm, that exclusion of sildenafil nonresponders in previously reported tadalafil clinical trials may not have substantially affected efficacy outcomes. Tadalafil improved erectile function in patients naïve to PDE5 inhibitor therapy and in patients who previously responded to sildenafil therapy.
Abstract: Our objective was to assess the effects of customized instructions and dose optimization on treatment satisfaction and improvement in erectile function (EF) with sildenafil citrate in men with erectile dysfunction (ED) who had not been previously treated with a phosphodiesterase-5 inhibitor. This 8-week, multicenter, open-label, flexible-dose (25, 50, or 100 mg sildenafil) study included 2 phases. During phase 1, patients took 50 mg sildenafil and followed the sildenafil sample package instructions. In phase 2, sildenafil dose could be adjusted on the basis of efficacy and tolerability, and investigators provided additional customized instructions. The primary efficacy variable was the satisfaction rate (defined as patients responding "very" or "somewhat" satisfied to the Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS] Question 1). Other efficacy assessments included the International Index of Erectile Function (IIEF) and the percentage of successful sexual intercourse attempts. Of 1109 men (mean age, 54+/-13 years) treated, 867 completed the study. In phase 1, 75% of patients were very or somewhat satisfied with treatment. Mean EF domain score on the IIEF increased from 14.3 at baseline to 23.5, and 79% of sexual intercourse attempts were successful. In phase 2, 53% of patients increased their sildenafil dose to 100 mg and 2% decreased to 25 mg. Satisfaction with sildenafil increased to 86%, 91% of sexual intercourse attempts were successful, and mean IIEF EF domain score increased to 25.7. Of the 196 men who were not initially satisfied at the end of phase 1, 64% became very or somewhat satisfied with treatment by the end of phase 2. Initially high levels of efficacy and satisfaction with sildenafil were achieved when patients were provided with only the sample package instructions and the recommended 50-mg starting dose. These results were enhanced with dose optimization, individual patient counseling, and customized instructions.
Abstract: OBJECTIVES: To describe the range of sexual problems, as reported by men calling a help-line and to investigate factors associated with help seeking behaviour. METHODS: The study included all calls between 1999 and 2004. The information used for analysis comprised caller's demographic characteristics, the sexual problem reported, previous doctor contacts, coexisting physical and mental health problems. RESULTS: Erectile dysfunction (ED) and premature ejaculation (PE) were the most frequently reported problems (57 and 19.2% respectively). ED-reporting callers were older (OR 0.63 for the ages of 50-59 yrs), with co-morbidities (OR 1.75) and in stable relationship (OR 0.46), while PE-reporting callers were younger (OR 5.83 for the ages of 20-29 yrs), relatively healthy and more likely single (OR 2.62 and OR 2.92 respectively). Type and duration of sexual concern, age, coexisting health problems and marital status relate significantly (p<0.01) with willingness to seek medical help. CONCLUSIONS: The study demonstrates that ED and PE are men's major sexual concerns with personal and interpersonal factors influencing their help-seeking behaviour. Help-lines can serve as a link between health services and callers, while provide useful information for policy formation and improvement of support services.
Abstract: The introduction of new oral therapies has completely changed the diagnostic and therapeutic approach to erectile dysfunction. A panel of experts in this field has developed guidelines for the clinical evaluation and treatment based on the review of available scientific information.
Abstract: INTRODUCTION: The Erectile Dysfunction Observational Study (EDOS) is a 6-month, pan-European prospective, observational study of health outcomes designed to assess patients' profiles and characteristics and the effectiveness of erectile dysfunction (ED) treatment in routine clinical practice. AIM: To present baseline characteristics and treatment-seeking behavior of a large sample of ED patients recruited in real-life clinical settings. METHODS: Men aged 18 years and older who visited a physician to initiate or change any ED treatment were enrolled in EDOS. They were assessed at baseline, 3 months, and 6 months as part of their normal course of care in nine European countries. MAIN OUTCOME MEASURES: Sexual health outcomes using the short form of the Psychological and Interpersonal Relationship Scales. Treatment effectiveness and satisfaction were assessed using the International Index of Erectile Function questionnaire, Global Assessment Questions, and further single-item questions. RESULTS: Of the 8,186 patients enrolled by 904 investigators (69% general practitioners [GPs]) across nine European countries, 8,055 patients were eligible for analysis at baseline; 63.9% were ED treatment-naive. Of the total patient population, mean age was 56.5 years, mean body mass index (BMI) was 27.2 kg/m2, 18.3% were obese (BMI > 30 kg/m2), 42.5% had severe ED, and there was a high frequency of comorbidities and concomitant medication use. A similar proportion of the treatment-naive patients were seen by GPs (62.9%) and specialists (65.8%). In the treatment-naive group, there was a higher frequency of severe ED among ex-smokers, obese patients, and in those who drank no alcohol or excessive amounts of alcohol. CONCLUSIONS: Unmet need of treatment in ED is high; 66% of patients had experienced ED symptoms for 1 year or longer when they were looking for treatment. Severity seems to be related to treatment seeking.
Abstract: PURPOSE: To describe the development and assess the outcome of a workshop on erectile dysfunction (ED) management based on participating physicians evaluations. METHOD: The study involved physicians who attended a workshop offered throughout the country, during a 3-year period. The workshop included tutorials, video-based dramatizations, and role-play sessions. A pilot study investigated the workshop's impact on physicians' attitudes toward patient-centeredness and sexual behavior issues; Patient-Practitioner Orientation Scale (PPOS) and Cross Cultural Attitude Scale (CCAS) were administered before and after the course. New knowledge acquisition, quality of presentation, and workshop's usefulness in their clinical practice were the dimensions used for workshop's evaluation. Analysis used quantitative and qualitative methods. RESULTS: A total of 194 questionnaires were administered during the pilot study and the response rate was 53.6%. A shift in attitudes toward patient-centeredness and less judgmental attitude toward patients' sexual attitudes were revealed (total PPOS score and Sharing subscale: P < 0.05, CCAS: P < 0.001). Six hundred physicians were asked to evaluate the workshops and the response rate was 62.3%. The tutorial session for "medical treatment of ED" (P < 0.001) and the role-play on sexual history taking (P < 0.05) received higher evaluation scores. Qualitative analysis showed that the most frequently reported category referred to the appropriateness of role-play as a teaching and awareness-raising technique (31.25%); a need for changes in clinical practice and communication patterns was identified by 20% of the participants who stressed the necessity for multidisciplinary approach, as well as the adoption of a nonjudgmental attitude toward patients. CONCLUSION: Training courses on ED management, using a combination of tutorial and interactive sessions, constitute an effective way of providing knowledge, enhancing physicians' communication skills with ED patients, and influencing attitudes toward patient-centeredness in sexual issues. Such results strongly support the establishment of sexual medicine courses at continuing medical education curricula.
Abstract: PURPOSE: We investigated the prevalence of psychiatric morbidity in patients with erectile dysfunction (ED). MATERIALS AND METHODS: Consecutive patients who attended an andrology outpatient clinic complaining of ED were recruited for study purposes. ED severity was evaluated by the International Index of Erectile Function erectile function domain score. The psychiatric diagnosis was established by a semistructured clinical interview as well as by the Mini International Neuropsychiatric Interview 5 Diagnostic and Statistical Manual of Mental Disorders-IV. The Beck Depression Inventory was also incorporated as a complementary tool to assess depressive symptom severity. RESULTS: The study included 103 patients 20 to 76 years old (mean age +/- SD 47.06 +/- 14.78) with ED. Most patients were classified with moderate and severe ED (26.2% and 44.7%, respectively). A detectable psychiatric condition was present in 63.1% of the patients, including depressive disorders in 25.2%, anxiety disorders in 11.7%, depression-anxiety comorbidity in 6.8% and personality disorders in 5.8%. A positive psychiatric anamnesis was identified in 41 cases, while 24 were newly diagnosed. No significant association was found between the duration and severity of ED, and psychiatric morbidity or the severity of depressive symptoms (p > 0.05). A positive association was found between the severity of depressive symptoms and the patient tendency to discuss the problem with their partner (p < 0.01). CONCLUSIONS: Psychiatric morbidity is highly prevalent in patients with ED, potentially affecting treatment outcome. Because lifetime psychological problems were reported by more than half of the patients, a psychosocial history seems mandatory. Partner support appeared to have a significant role in the patient psychological state.
Abstract: BACKGROUND: The efficacy and tolerability of vardenafil hydrochloride in men with erectile dysfunction (ED) and a history of nonresponse to sildenafil citrate have previously been reported. OBJECTIVE: The aim of this descriptive analysis was to assess the efficacy and tolerability of vardenafil at various times after dosing in men with ED and a history of nonresponse to sildenafil and who chose to attempt sexual intercourse between 0.25 and 6 hours after dosing with vardenafil. METHODS: This analysis used data from a previously published 12-week, prospective, randomized, double-blind, flexible-dose, placebo-controlled study conducted at 41 hospitals and outpatient clinics across Australia, Europe, Asia, and North America. In that study, men with ED and sildenafil nonresponse, defined using 6 rigorous criteria (including nonresponse to the highest recommended dose, 100 mg/d) were assigned to receive vardenafil 10 mg or placebo QD. At study weeks 4 and 8, patients in both groups were given the option to maintain the 10-mg/d dose, or have the dose titrated to 5 or 20 mg/d. The present analysis used data from patient diaries completed daily, which included information concerning attempts at sexual intercourse, time from dosing to attempt, penetration, and maintenance of erection sufficient for successful intercourse. At week 12, diary data were categorized into time intervals (in hours) after dosing. For each interval, the per-patient success rate was based on the total number of attempts made in that interval. Comparative statistics were not performed on the time-interval analysis. Tolerability was monitored throughout the study. Data concerning the primary end point were reported previously. RESULTS: A total of 463 men were enrolled, of whom 457 were included in the safety analysis (vardenafil, n = 231; placebo, n = 226) and 454 in the intent-to-treat analysis (vardenafil, n = 229; placebo, n = 225; mean age, 60.1 vs 59.0 years; mean body mass index, 28.7 vs 28.0 kg/m2). Six patients were excluded from the safety analysis (2 patients did not use study medication [placebo group], postbaseline safety data unavailable in 4 patients [2 in each study group]). Men receiving vardenafil had numerically greater penetration and completion success rates compared with those receiving placebo at all time intervals. Penetration success rates were numerically higher with vardenafil compared with placebo as early as within 0.25 hour after dosing (62% vs 30%); efficacy continued beyond 6 hours after dosing in 77% and 50% of patients, respectively. Similarly, vardenafil-treated patients had numerically greater completion success rates compared with those receiving placebo at 0.25 hour (53% vs 12%) and beyond 6 hours after dosing (70% vs 24%). The most common drug-related adverse events in the vardenafil and placebo groups were flushing (7% vs 1%), headache (6% vs 2%), and nasal congestion (5% vs <1%). CONCLUSIONS: This descriptive analysis suggests that erection sufficient for penetration and intercourse completion was achieved within 0.25 hour and lasted for >6 hours after dosing with vardenafil 10 mg in these men with mostly moderate to severe ED and a history of nonresponse to sildenafil and who chose to make attempts during those intervals. The drug was generally well tolerated.
Abstract: PURPOSE: Tadalafil, a new phosphodiesterase type 5 inhibitor, has an extended period of responsiveness compared with other agents in this class. The distinct pharmacological profile of tadalafil may allow more flexibility for men to establish individual sexual timing behavior patterns. We determined if patients took advantage of the pharmacological profile of tadalafil by assessing the frequency, timing and success of intercourse attempts in men with erectile dysfunction. MATERIALS AND METHODS: Data on Eastern European countries were combined from 2 identically designed, randomized, double-blind, placebo controlled, parallel group studies. Patients self-administered 20 mg tadalafil (406) or placebo (108) as needed for 12 weeks. RESULTS: Of the men 63% made at least a quarter of their attempts and 42% made at least half of their attempts more than 4 hours after dose. At least 1 attempt was made after 8, 12 or 24 hours after dose by 87%, 75% and 52% of the men, respectively. Throughout a 36-hour post-dose period tadalafil was associated with significantly higher intercourse success rates than placebo (p <0.001) with 61% to 69% of tadalafil treated patients reporting success rates of greater than 75% compared with 19% to 30% of those on placebo (p <0.001). Tadalafil was well tolerated. CONCLUSIONS: In this study various use patterns of the tadalafil period of effectiveness were apparent, reflecting differences in the sexual timing behavior of patients. Tadalafil may provide men with erectile dysfunction more flexibility in deciding when to attempt intercourse in accordance with their sexual habits and attitudes.
Abstract: OBJECTIVE: The objective of this study was to identify factors that affect efficacy response rate to sildenafil in the clinical practice. MATERIAL AND METHOD: The study comprised 100 consecutive sildenafil non-responders. Mean patient age was 59+/-14.4 years and mean duration of ED 5.5+/-6.4 years. All patients underwent detailed medical and sexual history and completed the IIEF and a questionnaire regarding the previous use of sildenafil. When inadequate instructions were reported, information on the appropriate use of sildenafil was given and patients were asked to use at least 4 tablets at home. Pharmacologic efficacy was re-evaluated in a scheduled follow-up visit. RESULTS: Mean Erectile Function Domain (ED) of the IIEF score was 14+/-9.9. In 56 patients inappropriate use of sildenafil was recognized; 45 had never used the highest recommended dose (100 mg), 32 had taken the pill with a full stomach right after a meal, 22 had taken the pill just before the initiation of sexual activity and 12 were not aware that sexual stimulation was mandatory to achieve an erection. Furthermore, 8 patients had tried the 100mg dose, despite the presence of factors associated with sildenafil clearance reduction (renal insufficiency, cimetidine treatment). Only 34 patients reported that their physician had scheduled a follow-up visit. Following adequate dose titration and time adjustment, 31 patients responded to sildenafil; 10 patients used the 50 mg dose and 21 the 100 mg. Second and third-line treatment options were offered to the rest of the patients. CONCLUSIONS: ED patients may receive inadequate instructions with their prescriptions. Response rate to sildenafil may be maximized after receiving appropriate dose titration and instructions on administration. ED should be treated in the same way as other chronic conditions; follow-up is necessary to evaluate the appropriate application and pharmacologic efficacy of the proposed treatment.
Abstract: Recent studies have highlighted the relation between erectile dysfunction (ED) and cardiovascular disease. In particular, the role of endothelial dysfunction and nitric oxide in ED and atherosclerotic disease has been elucidated. Given the large number of men receiving medical treatment for ED, concerns regarding the risk for sexual activity triggering acute cardiovascular events and potential risks of adverse or unanticipated drug interactions need to be addressed. A risk stratification algorithm was developed by the First Princeton Consensus Panel to evaluate the degree of cardiovascular risk associated with sexual activity for men with varying degrees of cardiovascular disease. Patients were assigned to 3 categories: low, intermediate (including those requiring further evaluation), and high risk. This consensus study from the Second Princeton Consensus Conference corroborates and clarifies the algorithm and emphasizes the importance of risk factor evaluation and management for all patients with ED. The panel reviewed recent safety and drug interaction data for 3 phosphodiesterase (PDE)-5 inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. Increasing evidence supports the role of lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease. Special management recommendations for patients taking PDE-5 inhibitors who present at the emergency department and other emergency medical situations are described. Finally, further research on the role of PDE-5 inhibition in treating patients with other medical or cardiovascular disorders is recommended.
Abstract: The field of erectile dysfunction (ED) has been revolutionised over the last two decades. Several treatment options are available today, most of which are associated with high efficacy rates and favourable safety profiles. A MEDLINE search was undertaken in order to evaluate all currently available data on treatment modalities for ED. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are currently the first-choice of most physicians and patients for the treatment of ED. PDE5 inhibitors have differences in their pharmacological profiles, the most obvious being the long duration of action of tadalafil, but there are no data supporting superiority for any one of them in terms of efficacy or safety. Sublingual apomorphine has limited efficacy compared with the PDE5 inhibitors, and its use is limited to patients with mild ED. Treatment failures with oral drugs may be due to medication, clinician and patient issues. The physician needs to address all of these issues in order to identify true treatment failures. Patients who are truly unresponsive to oral drugs may be offered other treatment options.Intracavernous injections of alprostadil alone, or in combination with other vasoactive agents (papaverine and phentolamine), remain an excellent treatment option, with proven efficacy and safety over time. Topical pharmacotherapy is appealing in nature, but currently available formulations have limited efficacy. Vacuum constriction devices may be offered mainly to elderly patients with occasional intercourse attempts, as younger patients show limited preference because of the unnatural erection that is associated with this treatment modality. Penile prostheses are generally the last treatment option offered, because of invasiveness, cost and non-reversibility; however, they are associated with high satisfaction rates in properly selected patients. All treatment options are associated with particular strengths and weaknesses. A patient-centred approach based on patient needs and expectations is necessary for the management of ED. The clinician must educate the patient and provide a supportive environment for shared decision making. The management strategy must be supplemented by careful follow-up in order to identify changes in patient health and relationship/emotional status that may necessitate treatment optimisation.
Abstract: Recent studies have highlighted the relation between erectile dysfunction (ED) and cardiovascular disease. In particular, the role of endothelial dysfunction and nitric oxide in ED and atherosclerotic disease has been elucidated. Given the large number of men receiving medical treatment for ED, concerns regarding the risk for sexual activity triggering acute cardiovascular events and potential risks of adverse or unanticipated drug interactions need to be addressed. A risk stratification algorithm was developed by the First Princeton Consensus Panel to evaluate the degree of cardiovascular risk associated with sexual activity for men with varying degrees of cardiovascular disease. Patients were assigned to 3 categories: low, intermediate (including those requiring further evaluation), and high risk. This consensus study from the Second Princeton Consensus Conference corroborates and clarifies the algorithm and emphasizes the importance of risk factor evaluation and management for all patients with ED. The panel reviewed recent safety and drug interaction data for 3 phosphodiesterase (PDE)-5 inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. Increasing evidence supports the role of lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease. Special management recommendations for patients taking PDE-5 inhibitors who present at the emergency department and other emergency medical situations are described. Finally, further research on the role of PDE-5 inhibition in treating patients with other medical or cardiovascular disorders is recommended.
Abstract: Erectile dysfunction (ED) is highly prevalent in men with cardiovascular disease (CVD), yet it is frequently underrecognized and underdiagnosed in clinical practice. Even among clinicians who acknowledge the relevance of addressing sexual issues in their patients, there is a general lack of awareness of the optimal approach for sexual problem identification and management. Additionally, cardiac rehabilitation programs typically neglect the role of sexual function. The trajectory of CVD and ED may necessitate continuous adjustment by both patients and their partners as they adapt to the chronicity of heart disease and the changing reality of their sexual lives. Health professionals typically approach management of these disorders from a disease-centered perspective, which often fails to incorporate the patient's needs and perspectives. In turn, patients frequently complain of a lack of sensitivity or awareness on the part of their physicians. From a patient-centered perspective, greater emphasis is placed on life satisfaction and quality of life as primary outcomes of treatment. Finally, a patient-centered framework is relevant for both treatment and prevention of cardiac risk in men with ED, in addition to ED management in patients with or without overt CVD.
Abstract: INTRODUCTION: Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed-dose and flexible-dose studies have previously established the efficacy and tolerability of vardenafil. AIM: To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence. METHODS: This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale. RESULTS: Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50-65% over the 4-12 week study period compared with 17-28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005). CONCLUSIONS: A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence.
Abstract: PURPOSE: To report female sexual problems and concerns, as presented by women calling a help-line, and to evaluate women's help-seeking behavior regarding sexual matters. MATERIALS AND METHODS: The study included all telephone calls from women who called for sexual concerns to a help-line dedicated to sexual problems during a 5-year period. During the call, the counselor addresses demographic characteristics of the caller, the sexual problem reported, their sexual function, any previous doctor contacts, coexisting physical and mental health problems, couple's relationship, and lifestyle factors that may influence sexual function. Data processing employed descriptive statistics and logistic regression analysis in order to detect possible associations between categorical variables. RESULTS: Of a total of 3,523 calls made by women, 2,287 full forms were analyzed, reflecting a response rate of 64.9%. Most women (46.6%) called for problems encountered by their partners, 45.1% called for their own sexual problems, while 5.9% were calling for their children. Only 34.3% of them had already consulted a doctor. The most frequently reported difficulties were achieving orgasm (25.6%), reduced sexual desire (16.9%), and pain during intercourse (6.1%). Women in the 40-49 age group had the higher odds ratios for the sexual problems reported (reduced sexual desire: odds ratio [OR] 5.0; difficulties achieving orgasm: OR 6.3; pain during intercourse: OR 5.8). Both married and single women had high risk of experiencing low levels of sexual desire (40% and 30%, respectively). CONCLUSIONS: Women's sexual concerns are not devoted to their sexual problems, but also their partner's and children's problems. Most frequently reported sexual problems are difficulties in reaching orgasm and reduced sexual desire. However, women are reluctant to seek medical advice on their sexual concerns. There is a need for general practitioners and family doctors to become aware of the possibility of a sexual problem and to be trained on how to manage this at a primary care level.
Abstract: INTRODUCTION: The optimal approach for identification and evaluation of the sexual problems in men and women in primary care or general medicine practice has not been consensed. AIM: To provide recommendations/guidelines concerning state-of-the-art knowledge for clinical evaluation and management strategies in the evaluation and treatment of sexual dysfunction in men and women, emphasizing evidence-based medicine and a patient-centered framework. METHODS: An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Clinical Evaluation and Management Strategies Committee, there were 12 experts from five countries. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. RESULTS: Three concepts underlie sexual medicine management: (i) adoption of a patient-centered framework for evaluation and treatment; (ii) application of the principles of evidence-based medicine in diagnostic and treatment planning; and (iii) use of a unified management approach in men and women. When taken together, these three principles provide a balanced and integrated approach to sexual dysfunction management. Common algorithms for diagnosis and management of men and women with sexual dysfunction, brief sexual symptom checklists, basics in history and physical examination, indications for specialized referral and development of a follow-up strategy are presented. CONCLUSIONS: More research is needed in understanding the role of evidence-based and patient-centered medicine in the clinical evaluation and management strategies of men and women with sexual dysfunction.
Abstract: INTRODUCTION: There are few published guidelines for the management of sexual dysfunctions in men and women, despite the prevalence and lack of attention to these problems. Disorders of sexual function in men include erectile dysfunction, orgasm/ejaculation disorders, priapism, and Peyronie's disease. AIM: To provide evidence-based and expert-opinion consensus guidelines for the clinical management of men's sexual dysfunctions. METHODS: An International Consultation in collaboration with major urological and sexual medicine societies assembled over 200 multidisciplinary experts from 60 countries into 17 consultation committees. Committee members established the scope and objectives for each chapter. Following intensive review of available data and publications, committees developed evidence-based guidelines in each area. MAIN OUTCOME MEASURE: New algorithms and guidelines for assessment and treatment of men's sexual dysfunction were developed. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of the medical literature, in addition to cultural and ethical considerations. RESULTS: Recommendations and guidelines for men's sexual dysfunction are presented. These guidelines were developed as evidence-based, patient-centered, and multidisciplinary in focus. For the clinical assessment and diagnosis of ED, a basic evaluation was recommended for all patients, with optional and specialized testing reserved for special cases. A new treatment algorithm is proposed. This algorithm provides a clinically relevant guideline for managing ED in the large majority of men. New treatment guidelines and algorithms are provided for men's orgasm and ejaculation disorders, including premature ejaculation, retrograde and delayed ejaculation. Finally, expert opinion-based guidelines for the clinical management of priapism and Peyronie's disease are provided. CONCLUSIONS: Additional research is needed to validate and extend these guidelines. Nonetheless, this summary encompasses the recommendations concerning men's sexual dysfunctions presented at the 2nd International Consultation on Sexual Medicine in Paris, France, June 28-July 1, 2003.
Abstract: Despite availability of outcome measures and scales for assessing erectile dysfunction (ED) treatment efficacy, guidelines are not available for assessing broader therapeutic outcomes or defining treatment failure in ED. An International Consensus Advisory Panel was convened to develop guidelines, definitions and a new algorithm for evaluating treatment effectiveness in ED. These new guidelines are recommended for use in both research and clinical practice. A multidisciplinary, international panel, consisting of 11 senior researchers and clinicians, was convened to address pertinent issues concerning therapeutic outcome assessment for ED. The panel utilized a modified Delphi method of consensus development and proposed a new model for outcomes assessment. This model is inherently testable, using existing instruments and current methods of assessment. Following a comprehensive literature review and discussion, the Panel recommended adoption of a new treatment effectiveness conceptual framework or theoretical model for assessing therapeutic outcomes in ED. Treatment effectiveness is presumed to be a combined function of two other factors, treatment response and treatment satisfaction. Treatment response is based on the combined assessment of efficacy and tolerability, and treatment satisfaction on the combined assessment of patient and partner satisfaction. Taken together, these two domains define an overall domain of treatment effectiveness. This therapeutic index would be derived by independently assessing treatment efficacy and satisfaction by means of event logs, questionnaires or the more typical patient interview methods. In conclusion, the Ad Hoc Advisory Consensus Panel recommends adoption of a new framework or conceptual model for conducting ED outcome trials or clinical research. The concept of 'treatment effectiveness' is proposed as a new 'umbrella concept' or distal outcome to be evaluated.
Abstract: Paratesticular masses can pose difficult diagnostic and therapeutic problems to the physician. We report a rare case of paratesticular liposarcoma with the clinical symptomatology of an inguinal hernia. The treatment was surgical and included radical orchiectomy and wide excision of the tumor mass to the macroscopically healthy margins. The patient is well and with no evidence of recurrence 1 year after the operation. We review the literature, and discuss the role of radical orchiectomy, radiation, and chemotherapy in the treatment of paratesticular liposarcomas.
Abstract: BACKGROUND: In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed. METHODS: In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions. RESULTS: The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient. CONCLUSION: In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED.
Abstract: OBJECTIVE: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil. PATIENTS AND METHODS: A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ). RESULTS: There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile. CONCLUSION: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).
Abstract: The purpose was to assess objectively and quantitatively the hemodynamic status and the degree of functional erectile impairment in a group of impotent patients. A clinical study was designed, incorporating pharmacocavernosometry (to evaluate arterial and veno-occlusive function) with axial buckling forces and penile geometry measurements in a group of impotent patients. The pressure gradient between the intracavernosal pressure associated with the presence of penile axial rigidity and the equilibrium intracavernosal pressure was calculated (axial rigidity gradient, ARG); such methodology allowed a quantitative characterization of functional impairment, as ARG expresses the intracavernosal pressure increase necessary to achieve axial rigidity and therefore potency. Penile geometry characteristics were also expressed by calculating the penile aspect ratio (diameter/length, D/L). In 83 consecutive patients tested (mean age 42.89+/-9.96), rigidity occurred at intracavernosal pressures between 50 and 100 mm Hg. A conversely proportional relation was noticed between penile aspect ratio values and the intracavernosal pressure associated with rigidity values, clearly demonstrating the important functional role of penile geometry. ARG demonstrated a wide range of values (3-69 mm Hg), reflective of the severity of the erectile dysfunction on each patient. Half (50.6%) of the patients had ARG values < or =20 mm Hg, indicative of minimal and minimal-to-moderate erectile impairment, while 20.48% had ARG between 21-30 and 28.92% >30 mm Hg, indicative of moderate and severe erectile dysfunction (ED) respectively. In all, 6% of the study group, all of them with primary ED, ARG <20 mm Hg had normal hemodynamics, but low penile aspect ratio values indicating that penile geometry may be the cause of insufficient rigidity. Hemodynamic integrity is the most critical, but not the only determinant of penile rigidity, as erectile impairment may be noticed in patients with normal arterial inflow and corporal veno-occlusive function. In such cases, unfavorable penile geometry should be considered as the possible etiological factor of impotence.
Abstract: To examine the hypothesis that the glans penis acts protectively, absorbing forces, during coitus. Five potent patients (mean age 46.8+/-9.7 y), who had indication for surgical excision of the glans for penile carcinoma were included in the present study. Intraoperatively, intracavernosal pressure (ICP) was adjusted by saline infusion and maintained by a pressure feedback infusion pump to a pressure value of 70 mmHg. Using a dynamometer, an external compressive force of 0.5 kg was applied at the glans penis and the changes in ICP were monitored. Measurements were repeated after surgical excision of the glans. Significant ICP changes were noticed in all patients after excision of the glans. Mean preoperative ICP was 161+/-11.5 mmHg, while after glansectomy it reached 206.6+/-13 mmHg. DeltaICP was 45.8+/-10.57 mmHg. Two of the patients' partners reported pain during intercourse postoperatively, possibly due to the impact of the force applied by the rigid corpora cavernosa on the anterior vaginal wall without any absorption by the glans. The glans penis restricts the increase in ICP during sexual intercourse, playing a protective role for both the corpora cavernosa and the female genitalia.
Abstract: PURPOSE: To investigate possible effects of sildenafil on the cardiopulmonary responses during sexual intercourse we evaluated cardiopulmonary responses during exercise in a group of impotent patients. MATERIALS AND METHODS: The study sample included patients with erectile dysfunction who underwent a cardiopulmonary exercise test before and after the administration of 100 mg. sildenafil citrate. Cardiopulmonary exercise test parameters at rest, at the anaerobic threshold, at peak exercise and at 1-minute recovery were recorded, including systolic and diastolic blood pressure, the heart rate, O2 consumption, CO2 production, ventilation and the respiratory rate. Furthermore, O2 consumption per kg. body weight, the ventilatory equivalent for O2 consumption (ventilation/O2 consumption) and CO2 production (ventilation/CO2 production), the respiratory quotient, metabolic equivalents metabolic equivalents, oxygen pulse (O2 consumption/heart rate) and the change in O2 consumption/change in heart rate were calculated. RESULTS: In 2 of the 43 patients enrolled in the study myocardial ischemia and high blood pressure were detected at rest in 2, respectively, who were excluded from analysis. In the remaining 41 patients with a mean age +/- SD of 52.3 +/- 8.6 years a statistically significant decrease in systolic and diastolic blood pressure was noted after sildenafil use at all stages tested (p <0.002 to 0.001). The heart rate mildly increased after sildenafil use at rest and at peak exercise (p = 0.018). The O2 pulse decreased at the anaerobic threshold (p = 0.003), peak exercise (p = 0.001) and recovery (p = 0.047). In the 11 patients with a mean age of 40.8 +/- 10.12 years who had psychogenic erectile dysfunction the only 2 parameters affected were an increased heart rate and decreased systolic blood pressure at rest, while O2 consumption/heart rate decreased at the anaerobic threshold. In the 18 patients with a mean age of 61.1 +/- 8.9 years who had organic erectile dysfunction and an unremarkable medical history a decrease was noted in systolic and diastolic blood pressure at rest and at peak exercise, and diastolic blood pressure also at recovery, while the heart rate increased at recovery. In the 12 patients with a mean age of 60.16 +/- 9.12 years who had treated cardiovascular disease systolic and diastolic blood pressure decreased at all states and O2 consumption/heart rate at the anaerobic threshold and at peak exercise, while increased values were noted for the respiratory rate at the anaerobic threshold and ventilation/CO2 production at recovery. CONCLUSIONS: Hemodynamic changes after sildenafil administration should be considered minimal in concert with patient health status. Younger patients without signs of systemic atherosclerosis compensate the vasodilatory effect of sildenafil during exercise, while in older patients with vasculogenic erectile dysfunction moderate changes may be noted regardless of cardiovascular disease in the medical history.
Abstract: PURPOSE: A Nesbit or plication procedure for correcting penile deformities is associated with penile shortening, especially in patients with excessive curvature and/or rotation. On the other hand, grafting procedures are associated with poor postoperative results due to graft shrinkage and veno-occlusive dysfunction. To minimize penile shortening and preserve potency we describe a new surgical technique combining the Nesbit procedure with tunica albuginea free grafting. Long-term functional results and patient satisfaction are reported. MATERIALS AND METHODS: We treated 17 potent patients with a mean age plus or minus standard deviation of 46.1 +/- 14.5 years, including 4 with congenital penile deviation and 13 with stabilized Peyronie's disease. Opposite the point of maximal curvature a typical Nesbit procedure was performed. The excised tunica albuginea segment consequently served as a free graft. A symmetrical incision was made at the opposite site and the preserved elliptical tunica albuginea graft was placed in the defect. Further elliptical excisions and grafting followed as needed to correct the deformity. RESULTS: At a mean followup of 39.5 +/- 13.7 months (range 18 to 62) all patients reported penile straightening and functional erection, while ultrasonography of the corpora cavernosa revealed no changes in graft ultrastructure. There was penile shortening in 8 patients (47%) but only 2 (11.7%) considered it significant. All patients with a minimum 2-year followup were positive in regard to recommending the operation to others or repeating it if necessary. CONCLUSIONS: The newly described technique may be considered as a treatment option in patients with excessive penile curvature since shortening of the penile shaft is eliminated by 50% compared with the result of the Nesbit procedure. Tunica albuginea seems to be an appropriate grafting material since it prevents postoperative corporeal veno-occlusive dysfunction.
Abstract: PURPOSE: The necessity for a thorough diagnostic evaluation for erectile dysfunction has been questioned after the availability of effective oral therapies. We determined the impact of the different diagnostic steps on the management strategy for erectile dysfunction. MATERIALS AND METHODS: The study included all patients who presented at an andrology outpatient clinic during a 4-year period. Baseline evaluation included medical and sexual history, blood tests, physical examination and intracavernous injection test. Patients with normal initial screening were evaluated with specific diagnostic procedures. The results were analyzed to identify the diagnostic potential of each screening step separately. RESULTS: Overall 1,644 patients presented at the clinic during the study period, of whom 368 (22.4%) were excluded from study due to severe psychiatric (5.2%) or cardiovascular (2.7%) disease, or to a history of erectile dysfunction less than 3 months in duration (14.5%). In the remaining 1,276 patients with a mean age plus or minus standard deviation of 56 +/- 14 years, and a mean duration of erectile dysfunction of 4.9 +/- 3.4 years medical history revealed erectile dysfunction associated medical conditions in 57%, blood tests identified previously undiagnosed medical conditions in 6.2%, and physical examination and the intracavernous injection test were diagnostic in 13.9% and 2.6%, respectively. Initial screening was negative in 259 cases (20.3%), in which specific diagnostic procedures identified an underlying vascular pathology in 165 (12.9%) and unfavorable penile geometry in 16 (1.3%). The remaining 78 men (6.1%) had no evidence of organic disease. CONCLUSIONS: Baseline diagnostic evaluation for erectile dysfunction can identify the underlying pathological condition or erectile dysfunction associated risk factors in 80% of patients. Such screening may diagnose reversible causes of erectile dysfunction and also unmask medical conditions that manifest with erectile dysfunction as the first symptom. Specific diagnostic procedures may be limited in patients with primary erectile dysfunction or those without risk factors. Such clinical data support previously published guidelines for erectile dysfunction management.
Abstract: In the 3 y since its initial approval, sildenafil has become the most widely used treatment for erectile dysfunction (ED) and has been prescribed to more than 13 million patients worldwide. Significant improvements in erectile function have been demonstrated in double-blind, placebo-controlled studies in diverse patient populations. A significant treatment effect has been shown with sildenafil in men with ED and a history of diabetes, cardiovascular disease, minor depression, spinal cord injury and multiple sclerosis. In addition, promising results have been shown in patients with treated prostate cancer, end-stage renal disease, Parkinson's disease and spina bifida and in multiple-organ transplant recipients. Postmarketing data of the use of sildenafil in clinical practice confirm the efficacy and safety found in clinical trials and high satisfaction with treatment. Public awareness of the common occurrence of ED and the high likelihood of a potentially favorable response to an oral treatment increased dramatically with the introduction of sildenafil. Physicians, however, are still not comfortable with ED management, which negatively affects pharmacotherapy response rates and patients' compliance to treatment. Continuing medical education seems mandatory to overcome existing problems in ED management.
Abstract: Erectile dysfunction (ED) affects men of all ages and results in considerable distress and impact on quality of life for those who suffer from it. As ED is associated with a wide variety of under-lying conditions and cardiovascular co-morbidities, there is a requirement for diversity of treatment options and several factors must be considered to customise and optimise therapy. In the ideal holistic approach to management of the ED patient, both primary care and specialist physicians have an important role to play. This article reports on a sequential approach for the diagnosis and treatment of ED, with an emphasis on 'shared care'. The deliberations are based on a pan-European inter-disciplinary group that met at the Lygon Arms, UK on 22 February 2002.
Abstract: PURPOSE: We present 7 cases of arterial high flow priapism and propose management algorithms for the condition. MATERIALS AND METHODS: We studied 2 children and 5 adults with posttraumatic arterial priapism. Blood gas analysis and color Doppler ultrasonography of the corpora cavernosa confirmed the diagnosis in 4 adults, while 1 patient had already undergone cavernous artery ligation in elsewhere. In the children perineal compression resulted in detumescence, a sign that is proposed to be indicative of the diagnosis of arterial priapism (piesis sign) complementing physical examination. Mechanical compressive force was applied to the perineum of 1 boy, while the other received a watchful waiting program. All adults participated in an observation regimen except 1, who decided to undergo immediate embolization of the internal pudendal artery. RESULTS: Perineal compression led to the resolution of priapism in 1 child, while spontaneous resolution was noted in the other. An adult noticed spontaneous penile detumescence 3 to 4 months after trauma, which was attributable to site specific venous leakage and decreased, inflow in the contralateral cavernous artery. The patient underwent venous surgery and is on an intracavernous injection regimen. Successful embolization of the internal pudendal artery was performed immediately in 1 man and in the other 4 months after trauma due to social inconvenience. Adult patient 3 is still on the watchful waiting protocol (42 months), while the one who underwent cavernous artery ligation is receiving treatment for erectile dysfunction. CONCLUSIONS: Absent of long-term damaging effects of arterial priapism on erectile tissue combined with the possibility of spontaneous resolution or progressive concomitant hemodynamic abnormalities associated with blunt perineal trauma are suggestive of the introduction of an observation period in the management algorithm of high flow priapism. Such a period may help avoid unnecessary intervention and determine the impact of priapism on patient personal life. Perineal compression may be also added as part of the physical examination as a sign specifically indicative of arterial priapism.
Abstract: Since its approval in 1998, sildenafil citrate (Viagra) has been shown to be efficacious in >100 clinical trials involving >8000 men with erectile dysfunction (ED). In clinical practice, however, many men do not continue long-term use of sildenafil for a variety of reasons; thus, 6 different aspects of optimizing treatment with sildenafil are described here. (1) Intercourse success rates, considered a reflection of real-world effectiveness, were assessed in 1276 patients with ED. Results indicated that the cumulative probability of achieving intercourse success with sildenafil increased with the number of attempts, reaching a plateau after approximately 8 attempts. (2) A comprehensive disease management approach that included a medical history, physical examination, educational material about ED, modifications of risk factors/lifestyle changes, and counseling resulted in successful intercourse in 74% of 111 patients taking sildenafil. (3) A survey conducted among primary care physicians revealed that almost 50% did not routinely question their patients about ED symptoms, although it is known that most patients would prefer their physician to take the initiative. (4) Overall, 55% of 137 men who were previously not successful with sildenafil became successful after reeducation and counseling, which included information on patient and partner expectations, how to properly take the drug, titration to maximum dose, and a minimum trial of 8 attempts for efficacy assessment. (5) Many men with ED have underlying comorbidities or take multiple medications that are risk factors for ED. Controlling these risk factors in 521 men from a multispecialty clinic led to an overall intercourse success rate of 82%; patients with multiple risk factors were less likely to have intercourse success than men with only 1 risk factor. (6) Finally, treatment satisfaction is a pivotal factor in maintaining long-term ED therapy. In an open-label trial, 82% of 443 subjects reported treatment satisfaction with sildenafil. In summary, these findings highlight how important it is for physicians to take a more comprehensive, proactive approach when treating men with ED, including control of risk factors, instructions on how to properly take the drug, partner involvement, and follow-up visits. Using these recommended measures, most men with ED, including those whose treatment was previously unsuccessful, can be treated successfully with sildenafil.
Abstract: The introduction of new oral therapies has completely changed the diagnostic and therapeutic approach to erectile dysfunction. A panel of experts in this field have developed guidelines for clinical evaluation and treatment based on the review of available scientific information.
Abstract: The objective of this study was to determine the effects of oral phentolamine, administered before sleep, on nocturnal penile erectile activity of men with mild to moderate erectile dysfunction (ED). We studied five patients with mild to moderate ED (mean age 34.8 +/- 8.13 and mean duration of ED 31.8 +/- 23.5 months), in a double-blind, placebo-controlled, crossover study. All patients received oral phentolamine (Vasomax) at a dose of 40 mg and placebo for three consecutive nights respectively and were submitted to nocturnal penile tumescence and rigidity monitoring (NPTR) with the Rigiscan device. NPTR parameters of the two 3-night recordings were evaluated and compared. Administration of oral phentolamine before sleep was associated with a statistically significant increase in the number of erectile events with rigidity > or = 60% lasting > or = 10 min (P = 0.02), as well as the rigidity activity units (RAU) value per hour sleep, both at the base (P = 0.023) and the tip of the penis (P = 0.019). The number of events as measured by Rigiscan software (20% change in circumference), as well as tumescence activity units (TAU)/h values did not show any statistical difference. No adverse effects were recorded. It is concluded that oral phentolamine administered before sleep enhanced NPTR parameters associated with the quality of the erectile events. Such results provide a pathway for the development of a prevention strategy for ED. Future studies will elucidate whether vasoactive agents taken on a regular basis before sleep, can prevent ED in men at risk, protecting also minimally and moderately impotent patients to become moderately and severely impotent respectively.
Abstract: OBJECTIVES: To present the surgical excision of the glans penis (glansectomy) as an alternative surgical treatment to penectomy. Buschke-Löwenstein tumors of the penis include the entities described in published reports as verrucous carcinoma and giant condyloma acuminatum of the penis. Both types are well-differentiated tumors, typically confined to the glans penis, with distinctly rare metastatic activity. METHODS: The study included 7 patients, 40 to 63 years of age, with exophytic, papillary lesions involving the glans penis. Biopsy led to the diagnosis of verrucous carcinoma in 4 patients and giant condyloma acuminatum in 3 patients. All patients reported normal erectile function. Because of the low malignant potential of the tumor and its confinement to the glans penis, a simple glansectomy was performed in all patients to preserve the maximal penile length and functional integrity of the corpora cavernosa. RESULTS: The postoperative course was uncomplicated. With 18 to 65 months of follow-up, all patients were disease free. One patient required more aggressive treatment because of local recurrence of the tumor. All patients returned to normal sexual activity 1 month postoperatively. The only change during sexual activity, noted by two of the patients' partners, was vaginal pain, possibly due to the absence of the glans. CONCLUSIONS: Glansectomy may be considered the treatment of choice in patients with Buschke-Löwenstein tumors of the penis, with more radical techniques reserved for second-line treatment.
Abstract: BACKGROUND: Benign prostatic hyperplasia (BPH) involves qualitative and quantitative alterations in extracellular matrix (ECM) components affecting stromal-epithelial interactions. Glycosaminoglycans (GAGs) are polysaccharide components of the ECM whose role in the development of BPH is under investigation. METHODS: GAGs were extracted from human prostates of normal and BPH origin and were subsequently fractionated through DEAE-sephacel anion exchange chromatography. The isolated GAG fractions were identified through electrophoresis on cellulose acetate membranes and treatment with GAG-degrading enzymes of known specificity. Their size distribution was determined through gradient polyacrylamide gel electrophoresis. RESULTS: Isolated prostatic GAGs included hyaluronic acid (HA), heparan sulphate (HS), and a mixture of dermatan sulphate (DS) and chondroitin sulphate (CS). The CS/DS ratio was significantly higher in hyperplastic as compared to normal prostates. A difference was also observed with respect to the apparent molecular mass of the DS-CS mixture, which reflects the CS enrichment in BPH. GAGs isolated from hyperplastic prostates were more diverse in size as compared to the corresponding glycans from normal prostates. CONCLUSIONS: The apparent increase in CS and decrease in DS content in prostates of patients with BPH is in good agreement with the pathological manifestation of increased cell proliferation in hyperplastic prostate tissue, since these glycan molecules have been reported to increase and decrease cell proliferation, respectively. Identification of the responsible enzymes involved in the homeostasis of CS and DS may provide alternative targets for pharmacological intervention.
Abstract: The aim of this work was to isolate and characterise the glycosaminoglycans present in the different tissue structures of the human penis in view of their potentially significant role in the physiology of erection. Penile tissue samples were obtained from patients who underwent penectomy and were subsequently dissected into individual tissue structures. Total glycosaminoglycans were isolated and purified from tunica albuginea, corpora cavernosa and corpus spongiosum, following tissue mincing, ultrasonication, lipid extraction, extensive digestion with pronase and DNase, treatment with alkali-borohydride and ethanol precipitation. Isolated glycosaminoglycans were separated by cellulose acetate electrophoresis and fractionated by anion exchange chromatography on DEAE Sephacel columns. Different glycosaminoglycan fractions were identified using glycosaminoglycan-degrading enzymes of known specificity. Gradient polyacrylamide gel electrophoresis was used to determine the average molecular mass of the glycosaminoglycans. The corpus cavernosum and the corpus spongiosum extracts contained almost twice the amount of glycosaminoglycan-associated uronic acids as compared to the tunical extracts (1.47+/-0.09, and 1.49+/-0.15 as opposed to 0.75+/-0.15 microg/mg dry defatted tissue, respectively; S.E.M., n=5). With the exception of hyaluronic acid, the relative amount of individual glycosaminoglycan types varied significantly among extracts of different origin. Heparan sulphate was more abundant in cavernosal, dermatan sulphate in tunical, and chondroitin-6-sulphate in corpus spongiosum extracts. No structure-specific differences were detected with respect to the molecular mass distribution of each glycosaminoglycan type. Our study shows that the different structures of the human penis produce distinct profiles of glycosaminoglycans, which are well suited to the individual functional characteristics of these structures.
Abstract: PURPOSE: To our knowledge comparative data on the effectiveness of and patient preference for intracavernous injection therapy and sildenafil are still not available. We evaluated the efficacy of sildenafil as well as patient preference in a group of impotent men on intracavernous injection for more than a year. MATERIALS AND METHODS: Patients on intracavernous injection therapy for more than a year without neurological disease and/or a contraindication to sildenafil treatment were recruited for study. In phase 1 we determined the efficacy of 50 and 100 mg. sildenafil citrate at home. In phase 2 responders to sildenafil were asked to use the preferred dose orally for a month and choose intracavernous injection or sildenafil. In phase 3 patients were asked to continue either treatment for 3 more months. Patient preferences were reported at the end of phases 2 and 3. RESULTS: Of the 180 men recruited 155 with a mean age of 56.4 +/- 12.6 years on intracavernous injection for a mean of 26 +/- 9 months accepted and were included in our series. Overall 116 men (74.8%) responded to sildenafil during study phase 1. After 1 month of treatment 71 responders (61.2%) preferred to continue with the oral drug, 31 (26.7%) returned to intracavernous injection and 14 (12.1%) used each drug alternately. Three months later 74 of the 116 responders (63.8%) preferred oral treatment and 38 (32.8%) chose intracavernous injection, while 4 (3. 4%) continued to use each treatment alternately. CONCLUSIONS: Sildenafil is highly effective in intracavernous injection responders, although a certain group prefer to continue intracavernous injection. While sildenafil should be considered first line treatment, men with erectile dysfunction should be aware of all treatment options available because nonresponders to sildenafil may respond to intracavernous injection.
Abstract: OBJECTIVES: To characterize hemodynamically a functional/rigid erection and study the hypothesis that a positive intracavernosal injection test indicates normal arterial and corporeal veno-occlusive function. METHODS: 33 patients (mean age 39.5 +/- 9 years), who developed rigid erection during pharmacocavernosometry, included in the present study. The presence of axial rigidity was determined at steady state equilibrium intracavernosal pressure, by absence of buckling to axial force of 1 kg, applied to the erect penis and sustained for >/=15 min. Arterial and veno-occlusive hemodynamic parameters were analyzed. RESULTS: Flow-to-maintain at intracavernosal pressure 150 mm Hg and mean pressure decay values ranged between 0.5-13 ml/min and 5-85 mm Hg, respectively. Flow-to-maintain values >5 ml/min were noticed in 8 patients (24. 24%), while pressure decay values >45 mm Hg in 13 patients (39.39%). Pharmacocavernosography revealed moderate opacification of venous structures in 7 cases (21.21%). Abnormal systemic-cavernosal systolic arterial pressure gradients in both cavernosal arteries were noticed in 9 patients (27.27%). All patients with flow-to-maintain values >5 ml/min had normal arterial function. CONCLUSIONS: A functional/rigid erectile response may coexist with arterial insufficiency or corporeal veno-occlusive dysfunction. Presence of normal or borderline arterial inflow may compensate minimal or moderate veno-occlusive dysfunction, resulting in a functional - but not normal - erection. Such information is critical when the intracavernosal injection test is used for diagnostic purposes.
Abstract: PURPOSE: The extent to which hemodynamic erectile responses predict penile buckling forces has not previously been analytically investigated. An engineering study was performed to compare hemodynamic data with penile buckling force values. METHODS: Dynamic infusion pharmacocavernosometry studies in 21 impotent patients (age 43, range 24-62 y) were accomplished to obtain information during penile erection concerning hemodynamic values, penile buckling forces and their determinants: intracavernosal pressure, erectile tissue mechanical properties and penile geometry. RESULTS: In the 21 patients, discrepancies existed in several patients who demonstrated normal hemodynamic values (low flow-to-maintain and high equilibrium intracavernosal pressures) but elevated cavernosal compliance values and diminished penile buckling forces. There was poor correlation between cavernosal compliance and equilibrium intracavernosal pressure (r = -0.36); better correlation between compliance and expandability (r = -0.72) and best correlation between dimensionless compliance and the dimensionless product of expandability with equilibrium pressure (r = -0.88). These data implied that cavernosal compliance was dependent on multiple factors, not only equilibrium intracavernosal pressure. CONCLUSIONS: Hemodynamic indices which correlate with intracavernosal pressure alone do not predict penile buckling forces since the latter are dependent not only on intracavernosal pressure but also on penile geometry and erectile tissue properties. The most relevant tissue property in predicting adequate penile buckling forces is cavernosal expandability. A new impotence classification system and diagnostic algorithm based on the determinants of penile rigidity and not exclusively on hemodynamic responses in proposed.
Abstract: PURPOSE: We studied the reproducibility of nocturnal penile tumescence, rigidity evaluation criteria and the possible effects of sexual intercourse in young, healthy, potent male volunteers. MATERIALS AND METHODS: We recruited 12 male medical students 21 to 24 years old into the study. A disorder-free medical history, availability of a sexual partner and normal erectile function were the inclusion criteria. All subjects completed 3 sessions of 3 nights of recording using the RigiScan* device with at least a 3-day interval between recordings. During the last 3-night recording subjects were asked to have sexual intercourse at least once. Analysis of the recordings was focused on the best erectile event as well as on rigidity and tumescence activity units normalized per hour. RESULTS: The subjects completed 36, 3-night recordings. Of the total of 108 sessions 18 occurred after sexual intercourse. We analyzed 562 erectile episodes. All 3-night recordings included at least 1 episode of rigidity at the penile tip greater than 60% and more than 10 minutes in duration. Sexual intercourse did not significantly affect nocturnal penile tumescence and rigidity. When rigidity and tumescence activity unit values were normalized by the hour and expressed as mean values of the 3-night sessions, documented values became reproducible. CONCLUSIONS: At least 2 consecutive nights of recording are necessary to evaluate nocturnal penile tumescence and rigidity recordings. Nocturnal penile tumescence and rigidity with at least 1 erectile episode of tip penile rigidity greater than 60% and 10 minutes in duration may be associated with potency. Mean rigidity and tumescence activity unit values per hour of a recording may be used as objective parameters to measure overall erectile activity. In addition, sexual intercourse seems to decrease nocturnal penile tumescence and rigidity measurements, although not statistically significant. We anticipate that application of these criteria for nocturnal penile tumescence and rigidity evaluation will improve the diagnostic validity of the test. Future research will determine whether these criteria are too strict for the evaluation of aging men.
Abstract: PURPOSE: The least investigated physical determinant of penile rigidity has been penile tissue material properties. The goals in this study (Part I) were to define two penile mechanical parameters, cavernosal expandability X and tunical distensibility VE/VF, determine their magnitudes in humans and develop an analytical expression for penile volume as a function of these two tissue characteristics and intracavernosal pressure. METHODS: Dynamic infusion pharmacocavernosometry was performed in 21 impotent patients (age 43 +/- 19 y) to provide human geometric, hemodynamic and structural data. A mathematically derived model of hemodynamic and structural-dynamic characteristics of penile erection was developed (Parts I, II, III) incorporating penile tissue mechanical qualities. RESULTS: Cavernosal expandability X provided a measure of the ability to approach maximum volume at relatively low intracavernosal pressures. Tunical distensibility VE/VF denoted the maximal erect to flaccid penile volume ratio. The magnitudes of X and VE/VF in the study population were 0.04-0.17 mmHg-1 and 1.7-5.0 respectively. CONCLUSIONS: Enabling penile volume to be derived as a function of tissue mechanical characteristics and pressure, allows for penile rigidity to be expressed (in Part II) as a function of pressure, geometry and tissue qualities.
Abstract: PURPOSE: Penile buckling force was analytically described in terms of its constituents. In addition, theoretically-derived buckling force data were compared to clinically measured data and the influence of each constituent on penile buckling force data was assessed. METHODS: Using engineering buckling theory for a column, a mathematically-derived penile buckling model was developed which incorporated geometric and hemodynamic data obtained by dynamic infusion pharmacocavernosometry studies in 21 impotent patients (age 43, range 24-62 y) as well as penile tissue mechanical characteristics previously developed (Part I). RESULTS: In 17 of 21 patients the mean difference between theoretically derived and clinically measured buckling force data was 0.33 +/- 0.25 kg (r = 0.96). Factors which increased penile buckling forces were: (1) high intracavernosal pressure values (rigidity was related to pressure in an exponential-like fashion); (2) high penile aspect ratio (D/L) values (relatively large diameter/short length penile geometry) and high flaccid diameter; and (3) high cavernosal expandability values (a measure of the ability of the corpora to approach its erect volume with relatively low intracavernosal pressures). CONCLUSIONS: Pressure-volume data (pressure, geometry and tissue characteristics) obtained during erectile function testing have been shown, for the first time, to theoretically predict the magnitude of clinically-measured penile buckling forces.
Abstract: During the last fifteen years the field of erectile dysfunction has grown tremendously, offering several treatment options to impotent patients, such as intracavernosal pharmacotherapy, vacuum therapy, penile vascular surgery and penile prosthetic surgery. Several multicenter clinical trials have been undertaken and numerous studies have been published, showing that the 'gold standard' treatment does not exist. As new oral, intraurethral and intracavernosal medications are added to the armamentarium of physicians and even more will be available for physicians and patients in the near future, the question becomes apparent: which treatment and when? The present paper critically reviews the existing information on currently available treatment options, and discusses future perspectives based on data from ongoing clinical trials. Considerations for the development of a new management strategy are also discussed.
Abstract: We describe a new methodology for direct ex vivo measurements of corporal stiffness. Using a new biosensor, stiffness of the corpora cavernosa was measured in 32 mature male Spraque Dawley rats. Mean stiffness (+/- se) value of the corpora was 8.186 +/- 0.318 gm/cm. The corpora was numerically the stiffest organ, when compared to the bladder and the prostate. Values measured at different points from both corpora showed a quite uniform stiffness (range 7.576-8.835 gm/cm). Hormonal stimulation with DHT was shown to significantly increase prostatic stiffness but not corpora stiffness. Similarly alpha-adrenergic antagonists did not affect corporal stiffness in a statistically significant manner. These results suggest that the influence of hormones and adrenergic stimulation on the passive properties of the corpora is negligible. It is concluded that this new method provides a reproducible new parameter for the measurement of corporal stiffness. It is anticipated that in the future this kind of stiffness measurement may be of use for the evaluation of the biomechanical properties of the corpora and its response to pharmacologic manipulation of the trabecular smooth muscle tone in vivo.
Abstract: A pharmaco-cavernosometry based clinical study was designed to define hemodynamic parameters consistent with complete trabecular smooth muscle relaxation, establish a methodology for overcoming incomplete trabecular smooth muscle relaxation, and determine under controlled conditions the contribution of venous outflow and arterial inflow to the steady-state equilibrium intracavernous pressure. Flow-pressure relationships were analyzed in 21 patients each of whom was assumed to have complete smooth muscle relaxation by virtue of the full, rigid and maintained erectile response following intracavernous vasodilator administration, which required intracavernous adrenergic agonists to achieve detumescence. Flow-to-maintain values increased linearly with intracavernous pressure while venous outflow resistance values were high and constant. Based on these relationships, trabecular smooth muscle tone was assessed in 123 impotent patients. In 14%, 63% and 14% of the patients (112 of 123 overall), respectively, 1, 2 and 3 doses of vasoactive agents were required to achieve hemodynamic relationships consistent with complete trabecular smooth muscle relaxation. In 9% of the patients such hemodynamic relationships were unable to be reached. In the 112 patients the influence of different engineering based measures of corporeal veno-occlusive function, including flow-to-maintain, pressure decay, venous outflow resistance and corporeal capacitance, was analyzed against the spectrum of equilibrium steady-state intracavernous pressures. Two distinct equilibrium pressure groups were identified reflecting different capacitance states: pressures greater than 60 mm. Hg (associated with low capacitance values) and pressures less than 50 mm. Hg (associated with high capacitance values), with pressures 50 to 59 mm. Hg representing a hemodynamic transition zone. When analyzed during complete trabecular smooth muscle relaxation, corporeal veno-occlusive hemodynamic variables in conjunction with cavernous arterial perfusion pressure determine the steady-state equilibrium intracavernous pressure. Failure to assess corporeal veno-occlusive function under such conditions will overestimate the degree of suspected corporeal structural disease.
Abstract: We provide current, normative data on the prevalence of impotence, and its physiological and psychosocial correlates in a general population using results from the Massachusetts Male Aging Study. The Massachusetts Male Aging Study was a community based, random sample observational survey of noninstitutionalized men 40 to 70 years old conducted from 1987 to 1989 in cities and towns near Boston, Massachusetts. Blood samples, physiological measures, socio-demographic variables, psychological indexes, and information on health status, medications, smoking and lifestyle were collected by trained interviewers in the subject's home. A self-administered sexual activity questionnaire was used to characterize erectile potency. The combined prevalence of minimal, moderate and complete impotence was 52%. The prevalence of complete impotence tripled from 5 to 15% between subject ages 40 and 70 years. Subject age was the variable most strongly associated with impotence. After adjustment for age, a higher probability of impotence was directly correlated with heart disease, hypertension, diabetes, associated medications, and indexes of anger and depression, and inversely correlated with serum dehydroepiandrosterone, high density lipoprotein cholesterol and an index of dominant personality. Cigarette smoking was associated with a greater probability of complete impotence in men with heart disease and hypertension. We conclude that impotence is a major health concern in light of the high prevalence, is strongly associated with age, has multiple determinants, including some risk factors for vascular disease, and may be due partly to modifiable para-aging phenomena.
Abstract: A retrospective multi-institutional study was performed to document and characterize the arterial vascular disease in the hypogastric-cavernous arterial bed and/or veno-occlusive dysfunction of the corpora cavernosa in patients with end stage renal disease. We evaluated 20 impotent patients (mean age 40 +/- 9 years) with chronic renal failure using pharmaco-cavernosometry and pharmacocavernosography (4 also underwent pharmaco-arteriography). Patients were divided into groups based on the treatment (14 with renal transplantation and 6 with hemodialysis or peritoneal dialysis), as well as by history of vascular risk factors (16 with and 4 without risk factors). Of the patients 19 revealed abnormal intracavernous pressure responses to repeated intracavenous injections of vasoactive agents implying vascular disease of the penis. Cavernous artery occlusive disease was found in 78% of the patients. All patients who underwent arteriography had diffuse atherosclerotic disease of the distal penile arteries. Corporeal veno-occlusive dysfunction was found in 90% of the patients, of whom 60% had diffuse pan-cavernous leakage involving the dorsal, cavernous and crural veins, glans penis and corpus spongiosum. This renal failure-associated vascular disease of the penis was found to occur independently of the presence of known systemic atherosclerotic vascular risk factors. Patients who underwent early treatment of the uremia by renal transplantation had vasculogenic impotence only in the case of rejection of the renal transplant, suggesting that early renal transplantation may delay or prevent the development of the penile vasculopathy. The most likely pathophysiology of the vascular impairment includes renal failure-associated atherosclerosis, and renal failure-associated hypoxia changes of the contractile (smooth muscle) and structural (collagen/elastin) components of the erectile tissue. Strategies for future research and clinical therapies are suggested.
Abstract: An animal model was established to study the effects of elevated intra-abdominal pressure (IAP) on systemic and renal hemodynamics during laparoscopy. In a pilot study in five dogs, we simultaneously recorded carotid artery blood flow (CABF), carotid artery blood pressure (CABP), inferior vena caval pressure (IVCP), renal parenchymal blood flow, and IAP. The renal parenchymal blood flow was measured by a laser Doppler flowmetry (LDF) needle probe and the renal artery blood flow by an ultrasonic Doppler probe, both placed through laparotomy. The reliability and reproducibility of these two measurements at different renal perfusion pressures were documented. The established method was then used to assess the effects of increased IAP on renal hemodynamics during laparoscopy in six pigs. Pneumoperitoneum was achieved by insufflating the abdominal cavity with air. The LDF needle probe was inserted into the renal parenchyma laparoscopically. An increase in IAP from 0 to 40 mm Hg did not influence CABP. However, significant decreases in CABF were seen from 190.8 +/- 59.5 mL/min at 0 mm Hg IAP to 169 +/- 43.6 mL/min at 15 mm Hg. The CABF decreased in a linear fashion as IAP was increasing (correlation coefficient R = 0.976). Renal cortical blood flow (RCBF) decreased from 50.1 +/- 17.7 mL/min per 100 g at 0 mm Hg to IAP to 21.2 +/- 9.6 mL/min per 100 g of tissue at 15 mm Hg. There was an exponential correlation between IAP and RCBF (R = 0.897).(ABSTRACT TRUNCATED AT 250 WORDS)
Abstract: During impotence evaluations a positive intracavernous injection test has been presumed to signify normal erectile hemodynamics. This premise was tested by obtaining hemodynamic data in 80 patients 17 to 65 years old with positive injection tests: patients achieved maximal circumference responses and equilibrium intracavernous pressures of 80 mmHg or more (range 80 to 136) sustained for 30 minutes or longer. Corporeal veno-occlusive testing revealed that flow-to-maintain (0.5 to 3 ml. per minute) and pressure decay (0 to 47 mmHg) values as well as pharmaco-cavernosography findings (absent or minimal contrast medium in venous structures in 92% of the cases) were all consistent with low outflow erection states. Arterial testing revealed right and/or left cavernous systolic arterial blood pressures always at 80 mmHg or more, consistent with a prerequisite cavernous artery pressure value for a positive injection test. Systemic-cavernous systolic arterial blood pressure gradients were 0 to 24 mmHg, 25 to 34 mmHg and 35 mmHg or more in 47 (59%), 18 (22%) and 15 (19%) patients, respectively. Large systemic-cavernous pressure gradients suggested the presence of arterial occlusive disease. In 8 patients with positive injection tests and gradients of 35 mmHg or more pharmaco-arteriography revealed hemodynamically significant arterial occlusions. In conclusion, hemodynamic data in selected patients with positive injection tests revealed low outflow erection states, threshold cavernous artery pressures and disparities in systemic-cavernous systolic pressure gradients that suggested arterial disease in 19% of the cases. The erectile response in a positive test is equal to or greater than a threshold response, not always the maximum response as determined by the systemic blood pressure. A positive intracavernous injection test did not necessarily signify normal erectile hemodynamics.
Abstract: The quality of the anastomosed vessels before vascular grafting has been shown to influence long-term patency rates in arterial reconstructive procedures. A study was designed to assess vascular graft quality during microvascular artery bypass procedures for impotence, correlate identified vasculopathy with the clinical history and gain insight into vascular pathophysiological mechanisms. A total of 194 donor or recipient vessel segments was biopsied in 111 patients with impotence who underwent microvascular artery bypass surgery during a 10-year period. A prospective histological grading system was used in a blinded randomized fashion. A preexisting vascular pathological condition was identified in 48% of the patients. Proliferative lesions above the internal elastic lamina with luminal stenosis were identified in 38 of 69 dorsal penile artery segments (55%) and 8 of 69 inferior epigastric artery segments (12%). Venous hypertrophy or sclerosis was observed in 13 of 56 deep dorsal vein segments (23%). Systemic atherosclerosis was likely the underlying pathophysiology of vascular disease in the inferior epigastric artery. Vasculopathy in the deep dorsal vein and the dorsal penile artery segments was probably related to the consequences of blunt trauma to the pelvis, perineum or penis, which was considered to occur following direct vessel wall injury with immediate or delayed vascular disease or indirect vessel wall injury secondary to proximal arterial occlusion and delayed distal vascular disease. Future studies are needed to investigate the relationship between preexisting graft vasculopathy in microvascular artery bypass surgery for impotence and long-term clinical success rates.
Abstract: Uncollected data must be filled in after the fact in many epidemiological studies. We compared several methods for constructing a surrogate variable for erectile potency, based on responses to related questions, in the Massachusetts Male Aging Study (MMAS). Quadratic discriminant analysis performed best among the procedures tested, achieving high rates of correct classification in cross-validation of training data and (according to posterior estimates) in classification of MMAS subjects. Two versions of the surrogate variable were constructed, one involving a discrete classification and the other involving a set of continuous probabilities. The two versions were used to investigate medical correlates of impotence in MMAS and produced similar results, although the continuous version appeared to provide higher statistical power. We conclude that construction of a surrogate variable is a viable and potentially beneficial option in epidemiological investigations.
Abstract: Endothelial injury in a deep dorsal vein graft may result from thermal, ischemic or mechanical trauma during surgical preparation or following exposure to systemic blood pressures and flow. We removed a functioning in situ deep dorsal vein graft section 10 months after microvascular arterial bypass surgery due to glans hyperemia. This section was compared and contrasted histomorphologically with a preoperative deep dorsal vein section that was procured for routine histological examination before the arteriovenous anastomosis. Detailed examination of the vein graft tissues by light microscopy, computer morphometrics and immunological staining demonstrated no evidence of vascular pathology. In the normal, healthy deep dorsal vein graft exposure to systemic arterial blood pressures and flow for 10 months did not result in myointimal proliferative lesions. Such histological changes seem more likely to be attributable to endothelial injury following iatrogenic surgical trauma. In situ vein grafts offer the opportunity to use "no-touch" endothelium preserving vascular techniques. Use of these grafts may improve long-term clinical results in penile microvascular arterial bypass surgery for impotence as it has in other vascular beds.
