Comparison Between On‐Demand Dosing of Dapoxetine Alone and Dapoxetine Plus Mirodenafil in Patients with Lifelong Premature Ejaculation: Prospective,Randomized, Double‐Blind,Placebo‐Controlled,Multicenter Study

IntroductionThere is partial evidence to support the use of phophodiesterase‐5 inhibitor (PDE5‐I) for the treatment of premature ejaculation (PE).AimWe compared on‐demand dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction (ED).MethodsOur prospective, randomized, double‐blind, placebo‐controlled, multicenter trial enrolled 118 subjects with lifelong PE without ED. PE was diagnosed using Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision. Patients were divided into two groups: dapoxetine 30 mg plus placebo (group A, n = 56) and dapoxetine 30 mg plus mirodenafil 50 mg (group B, n = 62).Main Outcome MeasuresDuring 12 weeks, intravaginal ejaculatory latency time (IELT) and the time from foreplay to beginning intercourse (FTIT) with a stopwatch, and Premature Ejaculation Profile (PEP) were measured. Overall sexual act time (OSAT; sum of FTIT and IELT) was calculated. Any treatment‐emergent adverse events (TEAEs) were also recorded.ResultsOver 12 weeks, IELT, OSAT, and PEP index score significantly improved in group B compared with group A (increased geometric mean IELT in group A and B = 3.6 and 6.1 minutes, P = 0.026; increased geometric mean OSAT in group A and B = 5.5 and 9.9 minutes, P = 0.012; increased median PEP index score in group A and B = 1.0 and 1.3, P = 0.046). However, there was no significant difference between two groups with respect to improvement of FTIT (P = 0.147). TEAEs did not differ between groups (all P > 0.05), and there was no serious adverse event in any subjects.ConclusionsLow dose of dapoxetine combined with mirodenafil showed better results in terms of IELT, OSAT, and PEP index score, and similar TEAEs, compared with that of dapoxetine only. Our results support the suggestion that the PDE5‐Is have a potential role in the treatment of PE without ED. Lee WK, Lee SH, Cho ST, Lee YS, Oh CY, Yoo C, Cho JS, Lee SK, and Yang DY. Comparison between on‐demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: Prospective, randomized, double‐blind, placebo‐controlled, multicenter study. J Sex Med 2013;10:2832–2841.     

Postnatal depression and post‐traumatic stress after childbirth: Prevalence,course and co‐occurrence

Research relating to the postnatal mental health of women has tended to focus on postnatal depression. There have been increasing calls to consider the issue of post‐partum anxiety disorders, including post‐traumatic stress disorder (PTSD). This study sought to provide further evidence regarding the prevalence and longitudinal course of post‐traumatic stress symptoms resulting from traumatic birth experiences. The study also investigated the extent to which symptoms of trauma and depression occur together in the postnatal period. Four hundred women were recruited from the maternity ward of a public hospital in South West Sydney. Symptoms of birth trauma and postnatal depression were assessed via questionnaires given at birth, 6 weeks, 6 months and 12 months post‐partum. The prevalence of having a PTSD profile at 6 weeks post‐partum was 2%. A further 10.5% of women reported experiencing significant distress related to childbirth and several symptoms of post‐traumatic stress without meeting full diagnostic criteria. The prevalence of a PTSD profile remained relatively stable across the first 12 months post‐partum, with estimates being 2.6% at 6 months and 2.4% at 12 months. The co‐morbidity between post‐traumatic stress and postnatal depression was high at all three time points. The study highlights the potentially chronic nature of PTSD after childbirth and the importance of viewing post‐partum emotional distress in a broader context than simply postnatal depression.     

Pilot Study on Quality of Life and Sexual Function in Men‐Who‐Have‐Sex‐with‐Men Treated for Prostate Cancer

IntroductionThere is limited data on post‐treatment quality of life (QoL) for men‐who‐have‐sex‐with‐men (MSM) with prostate cancer (PCa). QoL in MSM may not be reflected by assessment tools designed for the heterosexual population.AimsOur goals were to evaluate post‐treatment QoL in PCa patients who are MSM, and to investigate the utility of current QoL assessment tool.MethodsPCa patients treated with surgery and/or radiation were recruited from the local MSM community. Each participant completed the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, Male Sexual Health Questionnaire (MSHQ), and a questionnaire focused on insertive and receptive roles of anal intercourse.Main Outcome MeasuresResponse scores were calculated based on questionnaire design and compared by treatment modality.ResultsSeven participants treated with surgery (mean age 58) and eight participants treated with radiation (mean age 67) were recruited. No participant in the surgical group received androgen deprivation therapy (ADT) while two in radiation group were treated with ADT.The sample size of this study did not permit formal statistical analysis, although potential differences in Urinary and Bowel Domains from EPIC and Ejaculation Scale from MSHQ were observed. More participants from the radiation group seemed to be able to maintain both insertive and receptive anal intercourse roles after treatment compared to participants who received surgery.ConclusionsWhile the two validated assessment tools suggested similar QoL scores including sexual function for both surgical and radiation groups, post‐treatment sexual function related to anal intercourse may be better in the radiation group, as compared to the surgical group. Larger studies in PCa patients from MSM community are warranted to verify these data. Lee TK, Breau RH, and Eapen L. Pilot study on quality of life and sexual function in men‐who‐have‐sex‐with‐men treated for prostate cancer. J Sex Med 2013;10:2094–2100.     

Exploring Women's Postpartum Sexuality: Social,Psychological, Relational,and Birth‐Related Contextual Factors

IntroductionWomen's postpartum sexuality can be influenced by factors related to physical, personal, and relationship transitions after the newborn arrives. Despite this, many experiential and social factors remain unexplored.AimsThis study aims to (i) investigate a range of variables thought to influence postpartum sexuality; (ii) expand the focus beyond latency to penis–vagina intercourse; and (iii) assess positive aspects of postpartum sexuality.MethodsVia retrospective reporting on the first 3 months postpartum, 304 women completed an online questionnaire.Main Outcome MeasuresThe main outcome measures were retrospective reports of sexual desire (Sexual Desire Inventory), latency to resumption of sexual activity, and perceptions of partner's sexual desire. Other measures were birth experience (Questionnaire Measuring Attitudes About Labor and Delivery), breastfeeding status, perceptions of social support (Multidimensional Scale of Perceived Social Support), stress (Perceived Stress Scale), and body image (Body Image Self‐Consciousness Scale).ResultsSignificant differences in time to resumption were found. Women performed oral sex on their partners earlier than engaging in masturbation, which was followed by intercourse and then receiving oral sex. Post hoc analyses identified birth experience, social support, importance of partner's sexual fulfillment, and perception of partner's desire as contributors to this pattern. Women's postpartum sexual desire was influenced by their perceptions of their partner's postpartum sexuality and individual's level of fatigue. Results suggested that postpartum desire was not significantly influenced by breastfeeding status, vaginal issues, or psychosocial variables including stress, body image, or social support.ConclusionResults suggest that women's perceptions of their partner's sexuality impact postpartum sexuality more than the physical factors most commonly studied (e.g., vaginal trauma and breastfeeding). These results portray postpartum sexuality as a multidimensional phenomenon and highlight the need for further research that addresses its social context. Hipp LE, Kane Low L, and van Anders SM. Exploring women's postpartum sexuality: Social, psychological, relational, and birth‐related contextual factors. J Sex Med 2012;9:2330–2341.     

Sexual Function in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia: Results of a 6‐Month,Randomized, Double‐Blind,Placebo‐Controlled Study of Tadalafil Coadministered with Finasteride

IntroductionTadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described.AimAssess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED).MethodsA randomized, double‐blind, PBO‐controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks.Main Outcome MeasuresInternational Index of Erectile Function (IIEF) domain and single‐item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF‐Erectile Function domain scores (IIEF‐EF; MCID defined as ≥4‐point improvement); and sexual dysfunction adverse events (AEs).ResultsCompared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single‐item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF‐EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders.ConclusionsTAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well‐tolerated, regardless of the presence/absence of ED at treatment initiation. Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Büttner H, and Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Results of a 6‐month, randomized, double‐blind, placebo‐controlled study of tadalafil coadministered with finasteride. J Sex Med 2015;12:129–138.     

Sexual Communication,Dyadic Adjustment,and Psychosexual Well‐Being in Premenopausal Women with Self‐Reported Dyspareunia and Their Partners: A Controlled Study

IntroductionAlthough research that takes into account partner and relationship factors in dyspareunia is slowly emerging, little is known about how these couples communicate about their sexuality. Additionally, partner psychosexual adjustment has not been examined in a controlled fashion.AimThis study aimed to compare dyadic sexual communication, dyadic adjustment, psychological adjustment, and sexual well‐being of women with self‐reported dyspareunia and their partners with those of pain‐free control women and their partners.MethodsPremenopausal women (n = 38; mean [M] age = 24.92) with self‐reported dyspareunia, their partners (n = 38; M age = 26.71), as well as pain‐free control women (n = 44; M age = 25.86) and their partners (n = 44; M age = 27.95) completed an online survey measuring dyadic sexual communication, dyadic adjustment, anxiety, depression, sexual functioning, and sexual distress.Main Outcome MeasuresAssessments of women and men's (i) dyadic sexual communication; (ii) dyadic adjustment; (iii) anxiety; (iv) depression; (v) sexual functioning; and (vi) women's sexual distress were the main outcome measures.ResultsCompared with pain‐free controls, women with dyspareunia reported significantly poorer dyadic sexual communication, a difference not found between partners of women with dyspareunia and control partners. Compared with partners of control women, those of women with dyspareunia reported significantly more impaired sexual functioning. No differences in dyadic adjustment were found between women with dyspareunia and pain‐free control women, or between their respective partners. Finally, compared with control women, those with dyspareunia reported significantly more impaired psychological and sexual well‐being.ConclusionsFindings suggest that dyspareunia impacts not only the psychosexual adjustment of affected women but also that of their partners. It seems relevant to include both members of the couple in future research and treatment for dyspareunia. Pazmany E, Bergeron S, Verhaeghe J, Van Oudenhove L, and Enzlin P. Sexual communication, dyadic adjustment, and psychosexual well‐being in premenopausal women with self‐reported dyspareunia and their partners: A controlled study. J Sex Med 2014;11:1786–1797.     

Women with Preeclampsia Have Increased Serum Levels of Pregnancy‐Associated Plasma Protein A (PAPP‐A), Inhibin A,Activin A and Soluble E‐selectin

Objective. Poor placentation in early pregnancy is thought to lead to an excessive maternal systemic inflammatory response, which causes the maternal syndrome of preeclampsia. The aims of this retrospective study were to confirm old reports of increased blood levels of pregnancy‐associated plasma protein A (PAPP‐A) in preeclampsia and how its levels correlate with the levels of other placental and endothelial proteins that are reported to be elevated in preeclampsia. Methods. Nineteen women with preeclampsia symptoms were matched with 19 normal pregnant controls for gestational age, maternal age, and parity. PAPP‐A, placental pregnancy‐specific β₁‐glycoprotein (SP1), inhibin A, activin A, and sE‐selectin were measured in serum using specific ELISAs. Results. Maternal serum levels of PAPP‐A, inhibin A, activin A and sE‐selectin were increased in women with preeclampsia (mean 157.7 vs. 76.85 mIU/mL, p=0.005; 3.08 vs. 1.51 ng/mL, p=0.002, 32.36 vs. 3.77 ng/mL, p<0.001 and 62.15 vs. 46.37 ng/mL, p=0.02 respectively), compared to controls. Serum levels of SP1 were not altered in preeclampsia. PAPP‐A (r=0.636, p<0.01) had a positive correlation with sE‐selectin in patients with preeclampsia. Serum inhibin A and activin A had a significant positive correlation with each other in preeclampsia. Conclusions. Raised levels of PAPP‐A in preeclampsia confirm earlier reports. Activin A showed the highest increase over the controls and is thus likely to be a better serum marker for this pathology than the other markers that were tested.     

End‐of‐Life Care and Barriers for Female Inmates

The number of female inmates is growing, and their average age is increasing. As a result, end‐of‐life care is situated in a highly restrictive environment with a focus on security rather than comfort. We describe the need for and potential barriers to humane care and provide care strategies that can be useful in a complex organizational system. Frontline workers such as nurses who understand the balance between care and control must promote change in the women's prison system.     

Subcutaneous Mastectomy in Female‐to‐Male Transsexuals: A Retrospective Cohort‐Analysis of 202 Patients

IntroductionSubcutaneous mastectomy is the first surgical procedure to be completed by female to male transsexuals after appropriate mental health and endocrine therapy. Objectives of subcutaneous mastectomy in this group are to masculinize the chest by the removal of breast tissue and skin excess, reduction and proper positioning of the nipple‐areola complex, obliteration of the infra‐mammary fold, and ideally with a minimal of chest wall scars. In this study, the largest series of subcutaneous mastectomies in female‐to‐male transsexuals to date is presented.AimsOur aim was to determine relations between surgical technique, risk factors, complications, reoperations and secondary corrections in female‐to‐male transsexuals.MethodsWe performed a retrospective survey study on 404 mastectomies in 202 female‐to‐male transsexuals during the period of 2000–2011.Main Outcome MeasuresPrimary outcomes for this study were complication rate, acute reoperations, secondary corrections, surgical time, and length of hospital stay in relation to the surgical technique used.ResultsThe average age of these patients at time of the intervention was 31 years (±10) with an average BMI of 25 kg/m² (±4). The chosen technique depended strongly on breast volume, which, in turn, was strongly related to BMI and age. The number of acute reoperations and secondary corrections depended on the surgical technique. The total rate of acute complications was 5.0%. This percentage was highest in surgeries without skin resection (10.5%). To improve overall aesthetic results, the following secondary corrections were performed: nipple and/or areola corrections (8.9%), scar revisions (12.6%), and chest contouring (17.8%).ConclusionThis study shows a correlation between the surgical technique, complication rate, and length of hospital stay. In general, the larger the breast, the larger the scars that remain after the operation. On the other hand, the smaller the scars resulting from the operation, the higher the risk of hematoma. Cregten‐Escobar P, Bouman MB, Buncamper ME, and Mullender MG. Subcutaneous mastectomy in female‐to‐male transsexuals: A retrospective cohort‐analysis of 202 patients. J Sex Med 2012;9:3148–3153.     

Emotional Changes in Men Treated With Sildenafil Citrate for Erectile Dysfunction: A Double‐Blind,Placebo‐Controlled Clinical Trial

IntroductionErectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self‐esteem.AimIn men with ED, to use the validated Self‐Esteem and Relationship (SEAR) questionnaire to evaluate changes in self‐esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions.MethodsThis was a 14‐week, international, randomized, parallel‐group, double‐blind, flexible‐dose (25, 50, or 100 mg), placebo‐controlled study of sildenafil in men aged ≥18 years with a clinical diagnosis of ED (score ≤ 21 on the Sexual Health Inventory for Men).Main Outcome MeasuresThe primary outcome was the change in the SEAR Self‐Esteem subscale score from baseline to the end of treatment. Secondary outcomes were the change in SEAR component scores stratified by ED comorbidity, the change in the International Index of Erectile Function (IIEF) domain scores and in the intercourse success rate, and the response to the global efficacy assessment and to the global satisfaction assessment.ResultsA total of 841 patients were included in the intent‐to‐treat efficacy analysis (559 sildenafil, 282 placebo). Patients randomized to sildenafil had significantly greater change scores from baseline to the end of treatment on all components of the SEAR and all domains of the IIEF (P < 0.0001) compared with placebo. This finding was also consistent for all SEAR components when stratified by each ED comorbidity. In the sildenafil group, the improvement in the mean Self‐Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P < 0.0001).ConclusionsThe physiologic and emotional benefits of sildenafil in the treatment of ED were confirmed, overall and in men with comorbid hypertension, hyperlipidemia, benign prostatic hypertrophy, and/or depression. Using both the IIEF and the SEAR questionnaires provides a more complete assessment of ED. Moncada I, Martínez‐Jabaloyas JM, Rodriguez‐Vela L, Gutiérrez PR, Giuliano F, Koskimaki J, Farmer IS, Renedo VP, and Schnetzler G. Emotional Changes in men treated with sildenafil citrate for erectile dysfunction a double‐blind, placebo‐controlled clinical trial.     

Long‐Term Results of an Individualized,Multifaceted, and Multidisciplinary Therapeutic Approach to Provoked Vestibulodynia

IntroductionAlthough it is highly recommended to use a multifaceted approach to treat provoked vestibulodynia (PVD), the large majority of treatment studies on PVD used a one‐dimensional approach.AimTo evaluate the long‐term treatment outcome of a multifaceted approach to vulvar pain, sexual functioning, sexually related personal distress, and relational sexual satisfaction in women with PVD.MethodsRetrospective questionnaire survey 3–7 years after treatment.Main Outcome MeasuresSexual functioning, sexually related personal distress, and relational sexual satisfaction were measured using the Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS), and the Dutch Relationship Questionnaire (NRV), respectively. An additional questionnaire assessed socio‐demographic variables, intercourse resumption, and the level to which the women would recommend the treatment to other women with PVD. Post‐treatment vulvar pain scores were obtained using a visual analog scale (VAS). Pretreatment scores were reported in retrospect on a separate VAS.ResultsThe questionnaires were completed by 64 out of 70 women (91%). Mean follow‐up was 5 years (range 3–7). Comparison of the mean pretreatment and post‐treatment VAS scores showed a significant reduction in vulvar pain. Pain reduction was reported by 52 women (81%), whereas no change and pain increase were reported by 7 women (11%) and 5 women (8%), respectively. Post‐treatment, 80% of the women had resumed intercourse. Only 5 women (8%) reported completely pain‐free intercourse. Comparisons with age‐related FSFI and FSDS Dutch norm data showed that scores for sexual functioning in the study group were significantly lower, while scores for sexually related personal distress were significantly higher. There were no significant differences in relational sexual satisfaction ratings between the study group and the NRV Dutch norm data.ConclusionThese retrospective data on long‐term treatment outcome support the hypothesis that a multifaceted approach to PVD can lead to substantial improvements in vulvar pain and the resumption of intercourse. Spoelstra SK, Dijkstra JR, van Driel MF, and Weijmar Schultz WCM. Long‐term results of an individualized, multifaceted, and multidisciplinary therapeutic approach to provoked vestibulodynia.     

Nitric Oxide‐Releasing Polymeric Microspheres Improve Diabetes‐Related Erectile Dysfunction

IntroductionWe have used a long‐acting nitric oxide (NO)‐releasing polymer to develop injectable biodegradable microspheres capable of localized NO release over prolonged periods of time.AimThe aim of this study was to evaluate the therapeutic potential of these microspheres for diabetes‐related erectile dysfunction (ED) in the rat model.MethodsNO‐releasing microspheres were incubated in physiologic buffer, and in vitro NO release was measured using a Griess assay. To ensure no migration, microspheres were fluorescently tagged and injected into the corpus cavernosum of adult rats, and fluorescent imaging was performed weekly for 4 weeks, at which point rats were sacrificed. To assess physiologic efficacy, diabetes was induced in 40 rats using streptozotocin (STZ), whereas 10 rats were kept as age‐matched controls. Diabetic rats were divided into four groups: no treatment, sildenafil, NO‐releasing microspheres, and combination therapy. For each rat, the cavernosal nerve (CN) was stimulated at various voltages, and intracavernosal pressure (ICP) and mean arterial pressure (MAP) were measured via corpus cavernosum and carotid artery catheterization, respectively. Long‐term efficacy was determined by injecting diabetic rats with microspheres and measuring erectile response at predetermined intervals for up to 5 weeks.Main Outcome MeasuresErectile response was determined via calculation of mean peak ICP/MAP and area under curve (AUC) for each experimental group.ResultsUnder physiologic conditions in vitro, microspheres continued NO release for up to 4 weeks. Fluorescent imaging revealed no detectable signal in tissues besides cavernosal tissue at 4 weeks postinjection. Upon CN stimulation, peak ICP/MAP ratio and AUC of diabetic rats improved significantly (P < 0.05) in microsphere and combination therapy groups compared with no treatment and sildenafil groups. In long‐term efficacy studies, microspheres augmented the effect of sildenafil for 3 weeks following injection (P < 0.05).ConclusionsNO‐releasing microspheres significantly improved erectile response in diabetic rats for 3 weeks and hence offer a promising approach to ED therapy, either as monotherapy or combination therapy. Soni SD, Song W, West JL, and Khera M. Nitric oxide‐releasing polymeric microspheres improve diabetes‐related erectile dysfunction. J Sex Med 2013;10:1915‐1925.     

One‐Year Efficacy and Safety Study of a 1.62% Testosterone Gel in Hypogonadal Men: Results of a 182‐Day Open‐Label Extension of a 6‐Month Double‐Blind Study

IntroductionA new formulation of testosterone gel (1.62% testosterone gel) with increased viscosity and reduced volume of application has been shown to be safe and efficacious after 182 days of use in a phase 3, double‐blind study in adult hypogonadal males.AimThe objective of this study was to evaluate the efficacy and safety of the 1.62% testosterone gel after daily application to the skin in a 182‐day (6‐month) open‐label extension of the initial 182‐day double‐blind study.MethodsOne hundred and sixty‐three subjects, aged 26 to 77 years, continued on active (Continuing Active subjects) 1.62% testosterone gel for the remainder of the study (364 days total). In 28 subjects who had previously received placebo (Formerly Placebo subjects), the dose was titrated to normal levels of serum total testosterone (300–1,000 ng/dL). Dose adjustments for both groups were allowed at specific visits to maintain serum testosterone within a normal range.Main Outcome MeasureThe main outcome measure was the percentage of subjects with serum total testosterone average concentrations (C_av) within the normal range at day 364.ResultsOn day 364, 77.9% (95% confidence interval: 70.0, 84.6) of the Continuing Active subjects and 87.0% (66.4, 97.2) of the Formerly Placebo subjects had C_av values within the eugonadal range. The 1.62% testosterone gel was safe and well tolerated in this study.ConclusionTreatment with 1.62% testosterone gel for up to 1 year (182 days for the Formerly Placebo subjects, 364 days for the Continuing Active subjects) was safe and efficacious, resulting in >77% of treated subjects achieving normal serum testosterone levels at final visit. Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, and Brennan JJ. One‐year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: Results of a 182‐day open‐label extension of a 6‐month double‐blind study. J Sex Med 12;9:1149–1161.     

Erectile Dysfunction Is More Common in Young to Middle‐Aged HIV‐Infected Men than in HIV‐Uninfected Men

IntroductionErectile dysfunction (ED) is common among elderly men and patients suffering from chronic diseases, the latter probably including also HIV infection. No studies, however, compared the prevalence of ED in HIV‐infected and HIV‐uninfected individuals using the International Index of Erectile Function (IIEF‐15).AimThe aim of this study is to compare ED prevalence in young to middle‐aged men with and without HIV infection using the IIEF‐15 questionnaire.MethodsWe conducted a cross‐sectional, observational, controlled study on 444 HIV‐infected men and 71 HIV‐uninfected men.Main Outcomes MeasuresThe IIEF‐15 questionnaire was used to assess ED. A cutoff score of ≤25 of the erectile domain was used to diagnose ED. Serum testosterone, demographic, and anthropometric (weight, height, and body mass index [BMI]) characteristics were obtained from all participants. Statistics included the T‐test, the Fisher's test, univariable and multivariable logistic regression, and univariate and multivariate Spearman's correlation analysis.ResultsThe HIV‐uninfected group was significantly younger than the HIV‐infected group and presented a higher BMI (P < 0.001). The prevalence of mild, moderate, and severe ED was higher in HIV‐infected men than in HIV‐uninfected men of all decades of age. In univariate analysis, HIV infection was associated with ED (odds ratio [OR] = 34.19, P < 0.001). In multivariable logistic regression analysis, HIV infection remained the strongest predictors of ED (OR = 42.26, P < 0.001) followed by hypogonadism, after adjusting for age and BMI.ConclusionsThis study demonstrates a clear association between ED and HIV infection, after adjusting for age and BMI. Other than HIV infection, hypogonadism was associated with ED. In addition, the prevalence of ED was higher in HIV‐infected men than in HIV‐uninfected men, in all decades of age. The early onset of ED in HIV‐infected men could be considered a peculiar clinical hallmark of HIV and confirms precocious aging in these patients. ED should be of concern to clinicians when managing HIV‐infected men even if the latter are young or middle aged. Zona S, Guaraldi G, Luzi K, Beggi M, Santi D, Stentarelli C, Madeo B, and Rochira V. Erectile dysfunction is more common in young, middle‐aged HIV‐infected men than in HIV‐uninfected men. J Sex Med 2012;9:1940–1947.     

Associations Between Premature Ejaculation,Lower Urinary Tract Symptoms,and Erectile Dysfunction in Middle‐Aged Korean Policemen

IntroductionThere is controversy concerning the relationship between premature ejaculation (PE) and erectile dysfunction (ED), as well as the scan data regarding the association between PE and lower urinary tract symptoms (LUTS).AimsWe performed this study to evaluate the association between PE and ED or LUTS.MethodsA total of 2,591 policemen aged 40–59 years who had participated in a health examination were included in this study. PE, LUTS, and ED were evaluated using the premature ejaculatory diagnostic tool (PEDT), the International Prostate Symptoms Score (IPSS), and the International Index of Erectile Function questionnaire‐5 (IIEF), respectively. Spearman's correlation test, the multiple linear regression test, and logistic regression analyses were used to evaluate the relationship between PE and ED or LUTS.Main Outcome MeasuresAssociations between PEDT, IPSS, and IIEF.ResultsThe middle age of the study group was 49.1 years, and the middle PEDT, IIEF, and IPSS was 7.5, 17.0, and 10.7, respectively. By univariate analysis, PEDT showed a significant correlation with IPSS (r = 0.310, P < 0.001) and IIEF (r = −0.413, P < 0.001). After adjusting for age, components of metabolic syndrome, testosterone, and IIEF, PEDT was significantly correlated with IPSS (Beta = 0.166, P < 0.001). PEDT was also significantly correlated with IIEF after adjusting for age, components of metabolic syndrome, testosterone, and IPSS (Beta = −0.274, P < 0.001). Additionally, the severity of LUTS or ED was associated with the PE positive ratio (P trend < 0.001). The odds ratio (OR) for PE also increased with the severity of LUTS or ED after adjusting for potential confounding factors.ConclusionsED and LUTS were significantly and independently correlated with PE. Lee JH. Associations between premature ejaculation, lower urinary tract symptoms, and erectile dysfunction in middle‐aged Korean policemen. J Sex Med 2014;11:1512–1518.     

Corpus Cavernosal Smooth Muscle Relaxation Effect of a Novel AMPK Activator,Beta‐Lapachone

IntroductionAdenosine monophosphate‐activated protein kinase (AMPK) activation is suggested to relax smooth muscle by endothelial nitric oxide synthase (eNOS) phosphorylation.AimTo assess the mechanism and effect of a novel AMPK activator, beta‐lapachone, upon cavernosal smooth muscle relaxation and the therapeutic potential for erectile dysfunction.MethodsHuman umbilical vein endothelial cells (HUVECs) were treated with beta‐lapachone. The lysates were blotted with specific antibodies for phosphorylated AMPK (p‐AMPK) or phosphorylated eNOS (p‐eNOS). The membranes were re‐blotted for total AMPK total eNOS, or beta‐actin. The eNOS activity was measured by the conversion of L‐14C‐arginine to L‐14C‐citrulline in HUVECs lysates. In a separated experiment, cavernosal strips from New Zealand white rabbits were harvested for organ bath study and the relaxation effect of beta‐lapachone on phenylephrine‐induced contracted strips was evaluated and compared with sodium nitroprusside, zaprinast, metformin, and aminoimidazole carboxamide ribonucleotide (AICAR). Methylene blue and L‐NAME were used to assess the inhibition of cyclic guanosine monophosphate/nitric oxide pathway. Zinc‐protoporphyrin‐IX (ZnPP) was also used to investigate the contribution of mevalonate pathway.Main Outcome MeasuresThe expression of p‐AMPK, p‐eNOS, AMPK and eNOS induced by beta‐lapachone in HUVECs study and the percent relaxation of cavernosal tissue in organ bath study.ResultsBeta‐lapachone clearly induced AMPK phosphorylation and, as a consequence, eNOS phosphorylation in HUVECs. Beta‐lapachone‐induced upregulation of eNOS activity was also observed in HUVECs and steadily increased up to 1 hour. In organ bath study, beta‐lapachone significantly relaxed the phenylephrine pretreated strips in a dose‐dependent manner. This relaxation effect was not totally blocked by methylene blue or L‐NAME. After removing endothelium, the relaxation was totally blocked by ZnPP.ConclusionsA novel AMPK activator, beta‐lapachone has a strong relaxation effect on precontracted cavernosal smooth muscle strips in the rabbit. And phosphorylation of AMPK and eNOS strongly related to the action of beta‐lapachone. Mevalonate pathway also might be considered as a suggestive mechanism. Bae JH, Kim JW, Kweon GR, Park MG, Jeong K‐H, Kim JJ, and Moon DG. Corpus cavernosal smooth muscle relaxation effect of a novel AMPK activator, beta‐lapachone. J Sex Med 2011;8:2205–2214.     

Robot‐Assisted Laparoscopic Prostatectomy in Patients with Preexisting Three‐Piece Inflatable Penile Prosthesis

IntroductionRobotic‐assisted laparoscopic radical prostatectomy (RARP) is becoming the preferred surgical treatment option for management of organ‐confined prostate cancer. Although not a contraindication, previous pelvic surgery can make RARP challenging. Presence of a three‐piece inflatable penile prosthesis, with a perivesical pelvic reservoir, has the potential to induce steric hindrance making RARP difficult.AimThe main purpose of this publication is to report our experience with RARP in patients with previously inserted three‐piece inflatable penile prostheses.MethodsTwo patients with previously inserted AMS 700 penile prosthesis and with organ‐confined, biopsy proven adenocarcinoma of the prostate underwent RARP. We describe intraoperative findings, surgical technique, oncologic and functional outcomes.ResultsBoth patients underwent safe and successful RARP with out any complications. Surgical margins were not affected with pelvic reservoir‐sparing technique. In both patients, the penile prosthesis remained functional postoperatively.ConclusionsRARP can be safely performed in patients with previously inserted three‐piece inflatable penile prosthesis. Nontraumatic handling of the pelvic reservoir is mandatory to preserve prosthesis' integrity. Erdeljan P, Brock G, and Pautler SE. Robot‐assisted laparoscopic prostatectomy in patients with preexisting three‐piece inflatable penile prosthesis. J Sex Med 2011;8:306–309.     

Anatomic and Sexual Outcomes after Vaginoplasty Using Tissue‐Engineered Biomaterial Graft in Patients with Mayer‐Rokitansky‐Küster‐Hauser Syndrome: A New Minimally Invasive and Effective Surgery

IntroductionRecent years have seen continuous reports about the successful reconstruction of numerous organs with the application of tissue‐engineering techniques. Thus, we assess the outcomes for vagina reconstruction using tissue‐engineered biological material, which we suggested previously as an ideal graft for vaginoplasty.AimTo evaluate the anatomic and sexual outcomes in patients undergoing vaginoplasty using tissue‐engineered biomaterial mesh.MethodsThis prospective study included 53 patients with Mayer‐Rokitansky‐Küster‐Hauser syndrome admitted to our hospital. Patients underwent vaginoplasty with tissue‐engineered biological material (acellular dermal matrix). Postoperatively, a silicone vaginal dilator (length: 10 cm, diameter: 3.5 cm) was advised to be used for the first 3–6 months to prevent contraction of the neovagina. Follow‐up was performed at 4 weeks, 12 weeks, 12 months, and then annually. Twenty‐four age‐matched women who underwent health examinations during the same time period were selected as a health control group and answered Female Sexual Function Index (FSFI) questionnaires for the purpose of comparing sexuality.Main Outcome MeasuresAnatomic success was defined by a vaginal length ≥8 cm and a width allowing the easy introduction of two fingers. Sexual outcomes were assessed at the 12‐month follow‐up according to body image perception and FSFI questionnaires validated for the Chinese‐speaking population.ResultsNo severe intra‐operative complications occurred. No graft‐related infection, rejection, or detachment was recorded. The cost for tissue‐engineered biomaterial graft was $1,900 (¥12,000) per person. Postoperatively, granulomatous polyps occurred in 6/53 patients (11.3%) at the vaginal vault and were removed in an outpatient clinic. During a mean follow‐up of 21.1 months, the anatomic success rate was 100%, and all of the patients were satisfied with their body image. Postoperatively, 42 patients were followed up for more than 1 year, and 32 of them were sexually active. Among the 24/32 patients (75%) who answered the FSFI questionnaire, the mean total FSFI score was 26.7 ± 3.5, which was similar to that of the control group (25.6 ± 7.4, P = 0.46). The similarity was also observed in six separate domains of the functional aspect of female sexuality.ConclusionsVaginoplasty with tissue‐engineered biomaterial graft is a safe, effective, minimally invasive cosmetic procedure that provides near normal sexual function for patients with vaginal aplasia.