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The article presents abstracts of research on sexual medicine. They include "Erection Hardness Is Critical for Good Sex and a Healthy Relationship: The Global Better Sex Survey," "Severe Obstructive Sleep Apnea Syndrome Is Associated With Female Sexual Dysfunction" and "Time Effect on Potency in Post-Radical Cystectomy Patients: Subjective and Objective Evaluation."

The article discusses research on the safety and effectiveness of collagenase clostridium histolyticum (CCH) treatment in patients with Peyronie's disease in European Union (EU) patients compared to subjects enrolled in a phase three open-label study in the U.S., New Zealand and Europe. The research assessed improvement in penile curvature deformity and change in Bother domain of Peyronie's disease, as well as treatment emergent adverse events in the patient groups.

Introduction: Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment for Peyronie's disease (PD)., Aim: The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD., Methods: This phase 3, open-label study enrolled subjects who were CCH-naïve, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 CCH study. Each treatment cycle included two intralesional injections of CCH 0.58 mg, approximately 24-72 hours apart, and plaque modeling 24-72 hours after the second injection of each cycle. The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles., Main Outcome Measures: The co-primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score (range 0-16) from baseline to week 36., Results: Of the 347 subjects treated with ≥1 injection, 238 had both a penile curvature measurement and a Peyronie's Disease Questionnaire response at baseline and ≥1 subsequent time point. Mean baseline penile curvature deformity was 53.0° and mean PD symptom bother was 7.3. Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity (34.4% [95% confidence interval {CI}, 31.2%, 37.6%]) and PD symptom bother score (3.3 [95% CI, 2.8, 3.7]). Most adverse events (AEs) were mild or moderate in severity and local to the penis. There were three serious treatment-related AEs, two penile hematomas and one corporal rupture; all resolved with treatment., Conclusions: Potentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. CCH was generally well tolerated, with AEs primarily transient and local to injection site. In conjunction with previous studies, the results of this open-label study support the use of CCH in the treatment of PD., (© 2014 International Society for Sexual Medicine.)

Introduction: Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels., Aims: To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant., Methods: A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45-80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤ 4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Main Outcomes Measures.  Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question)., Results: Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤ 3 ng/mL., Conclusions: The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤ 3 ng/mL., (© 2010 International Society for Sexual Medicine.)

Introduction: Women's quality of sexual life is strongly impaired by erectile dysfunction (ED). Women's involvement in ED treatment is important for compliance and long-term efficacy but remains difficult. The Index of Sexual Life (ISL), specific of the quality of sexual life of women with ED partners, is used here to assess the impact of ED treatment on female partners., Aim: The study explored in a context close to routine clinical practice the effect of sildenafil citrate (Viagra(R); Pfizer, New York, NY, USA) treatment on women's quality of sexual life, in parallel with men's ED evaluations., Methods: This prospective, open-labeled clinical trial was performed in France in 2006. Sexologists and andrologists recruited 67 volunteer couples for a 14-week sildenafil citrate treatment of male partners, without sex therapy in parallel., Main Outcome Measures: Women's quality of sexual life using ISL, and men's ED using International Index of Erectile Function (IIEF) and Self-Esteem And Relationship (SEAR) were assessed at baseline and at the end of the study. Satisfaction for treatment was measured using Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and EDITS Partner., Results: The ISL sexual life satisfaction score was low at baseline (12.3), and increased by 8.3 during the study (P < 0.0001). Women were 79.0% to be responders according to ISL assessment. The other ISL dimensions also improved. The final ISL sexual life satisfaction score was dependant on women's age and final IIEF scores. The observed correlations between the ISL sexual life satisfaction dimension and the IIEF erectile function dimension, and the SEAR confidence dimension confirmed our assumptions. Both partners were highly satisfied with the treatment., Conclusion: Women satisfaction with their sex life was improved by ED treatment (sildenafil citrate). Couple global caring seemed to amplify the well-known effect of ED treatment for men. The ISL could be a useful tool to help women in their partner's treatment and to integrate ED treatment in a couple approach.

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.

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.