A novel on-demand therapy for lifelong premature ejaculation using a miniature transperineal electrical stimulator-the vPatch: an as-treated analysis.

BACKGROUND: While premature ejaculation (PE) is a common and disturbing sexual dysfunction in men, current available treatment modalities have limited efficacy and low treatment adherence. AIM: To assess the feasibility, safety, and efficacy of the vPatch, a miniaturized on-demand perineal transcutaneous electrical stimulation device for treating PE. METHODS: This prospective bicenter international first-in-human clinical study consisted of 2 arms, was sham controlled, and had a randomized double-blind design. In terms of statistical power calculation, 59 patients aged 21 to 56 years (mean ± SD, 39.8 ± 9.28) with lifelong PE were included. During the initial visit, intravaginal ejaculatory latency time (IELT) was measured over a 2-week run-in period. Eligibility was confirmed in visit 2, based on IELT values, medical and sexual history, and patients' individualized sensory and motor activation thresholds during perineal stimulation with the vPatch. Patients were randomized to the active (vPatch) and sham device groups in a 2:1 ratio, respectively. The vPatch device's safety profile was determined by comparing the incidence of treatment-emergent adverse events. During visit 3, IELTs, Clinical Global Impression of Change scores, and Premature Ejaculation Profile questionnaire outcomes were recorded. Primary end points assessed vPatch device efficacy as mean change in geometric mean IELT; each person was compared with himself, with and without the device, and the sham group was compared with the active group. OUTCOMES: Outcomes included changes in IELT and Premature Ejaculation Profile before and after treatment, last visit Clinical Global Impression of Change scores, and vPatch safety profile. RESULTS: Of 59 patients, 51 completed the study: 34 in the active group and 17 in the sham group. The baseline geometric mean IELT significantly increased from 67 to 123 seconds (P < .01) in the active group, as compared with an insignificant increase from 63 to 81 seconds (P = .17) in the sham group. The increase in mean IELT in the active group was significantly higher than in the sham group (56 vs 18 seconds, P = .01). IELT significantly increased by 3.1 times in the active vs sham group. The mean ratio of fold change (active:sham) was 1.4, significantly different from 1.0 (P = .02). No serious adverse events were reported. CLINICAL IMPLICATIONS: Therapeutic use of the vPatch during coitus may become an on-demand, noninvasive, and drug-free treatment for PE. STRENGTHS AND LIMITATIONS: To our knowledge, this is the first rigorous study investigating whether transcutaneous electrical stimulation during coitus could improve the symptoms of men with lifelong PE. The study is limited by the small number of patients, the exclusion of patients with acquired PE, the short-term follow up, and the use of a device based on a theoretic mechanism of action. CONCLUSION: We demonstrated the possibility to treat lifelong PE by prolonging coitus on demand, using electric stimulation of ejaculation muscles with the vPatch.Clinical trial registration: NCT03942367 (ClinicalTrials.gov).

Clinical Effects of Oral Supplementation of Gamma-Cyclodextrin Curcumin Complex in Male Patients with Moderate-To-Severe Benign Prostatic Hyperplasia-Related Lower Urinary Tract Symptoms.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTSs) in males. Curcumin exhibits anti-inflammatory and anti-tumor properties which may be effective for BPH. This multi-arm observational study evaluated the real-world efficacy of QURMIN® (Gamma-cyclodextrin-curcumin Complex-CAVACURMIN®) as single or combination therapy for BPH. METHODS: Men with moderate-severe LUTS/BPH, receiving a 6-month supplementation with QURMIN® alone or in combination with BPH-specific medication were propensity score matched with patients not taking curcumin and then divided into subgroups based on concomitant baseline treatment. Cohorts were compared in the 6-month variation of IPSS, quality of life (IPSS-QoL), Benign Prostatic Hyperplasia Impact Index (BII) and uroflowmetry parameters. Curcumin tolerability was evaluated in terms of discontinuations and adverse effects. RESULTS: The 1:1 propensity score matching resulted in a treatment-naïve (n = 152), an alpha-blocker only (AB) (n = 138) and AB + 5-alpha reductase inhibitors (5-ARIs) (n = 78) subgroup. After 6 months, drug-naïve patients taking curcumin reported significant improvement in IPSS-storage (-3.9, p < 0.001), IPSS-voiding (-2.0, p = 0.011), IPSS-total (-5.9, p < 0.001), IPSS-QoL (-3.9, p < 0.001), BII (-2.0, p < 0.001), Qmax (+3.1 mL/s, p < 0.001), Qmean (+1.9 mL/s, p = 0.005), post-void residual volume (-7.7 mL, p < 0.001), and PSA (-0.3 ng/mL, p = 0.003), compared to controls. Patients taking ABs and curcumin showed improvement in IPSS-storage (-2.7, p < 0.001), IPSS-voiding (-1.3, p = 0.033), IPSS-total (-3.5, p < 0.001), IPSS-QoL (-1.1, p = 0.004), BII (-1.7, p = 0.006), Qmax (+1.0 mL/s, p = 0.006), and PSA (-0.2 ng/mL, p = 0.01). Patients taking curcumin and AB + 5-ARI showed improvement in IPSS-storage (-1.3, p = 0.007), IPSS-total (-1.6, p = 0.034), IPSS-QoL (-1.1, p < 0.001), and BII (-2.0, p < 0.001). No adverse reactions were reported for curcumin supplementation. CONCLUSION: QURMIN® (CAVACURMIN®) led to significant improvements in symptom burden, uroflow parameters, and QoL, without significant additional side effects, thus proving to be a potential new treatment for BPH, either as a single therapy or in addition to standard treatment.

Satisfaction rate at 1-year follow-up in patients treated with penile implants: data from the multicentre prospective registry INSIST-ED.

OBJECTIVES: To investigate scores and predictors of patient satisfaction at 1 year after penile prosthesis implantation (PPI) using the validated Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. PATIENTS AND METHODS: Analyses were performed for 142 patients prospectively included in the national multicentre registry Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction (INSIST-ED), which provided 1-year follow-up data. Postoperative patient satisfaction was assessed using the validated QoLSPP tool. Linear logistic regression analyses assessed predictors of QoLSPP total and single domain scores, including age at surgery, erectile dysfunction aetiology, type of prosthesis, surgical approach, surgeon experience and complications. Locally weighted regression methods were used to explore the relationship between surgeon experience and QoLSPP scores. RESULTS: Overall, high median functional, relational, social, personal and total QoLSPP scores were reported at 1 year after PPI. Patients implanted with hydraulic devices had higher functional (23 vs 21.5; P = 0.01) and total scores (68 vs 65.5; P = 0.03) than those with a malleable prosthesis. Surgeon experience emerged as the only independent predictor of higher satisfaction scores, depicting a non-linear association with both QoLSPP total and single domain scores (all P < 0.03). Data suggested that the higher the number of procedures per year, the greater the satisfaction scores, reaching a plateau after l5 procedures/year. CONCLUSIONS: This study reports high functional and patient satisfaction scores at 1 year after PPI surgery using a dedicated tool for the first time. Better outcomes should be expected for patients treated by surgeons with greater experience.

Predictors of treatment success after collagenase Clostridium histolyticum injection for Peyronie's disease: development of a nomogram from a multicentre single-arm, non-placebo controlled clinical study.

OBJECTIVE: To build a nomogram able to predict treatment success after collagenase Clostridium histolyticum (CCH) for Peyronie's disease (PD). MATERIALS AND METHODS: Between November 2016 and November 2017, we enrolled 135 patients with PD into a multicentre single-arm prospective study. All patients enrolled received CCH treatment. Success of therapy was defined as a decrease in penile curvature (PC) of ≥20° from baseline. Treatment satisfaction was assessed using a scale from 1 to 10, and high satisfaction was arbitrarily defined as a score of ≥8. Calcification level was classified as: absence of calcification; low perilesional calcification; and high calcification. RESULTS: The median (interquartile range [IQR]) patient age was 56.0 (45.0-65.0) years and the median (IQR) was PC was 30 (30.0-60.0)°. After the treatment protocol, we observed a significant median change in PC of -20.0° (P < 0.01). The median (IQR) PC improvement was 44 (28.0-67.0)%. Overall median (IQR) satisfaction score was 8.0 (7.0-9.0). Treatment efficacy was reported in a total of 77 patients (57.04%). When analysing factors associated with PC improvement after treatment, we found that baseline PC (odds ratio [OR] 1.14; P < 0.01), basal plaque (OR 64.27; P < 0.01), low calcification (OR 0.06; P < 0.01) and high calcification (OR 0.03; P < 0.01) were significant predictors of PC improvement. The c-index for the model was 0.93. CONCLUSIONS: Patients with longer PD duration, greater baseline PC and basal plaque location had a greater chance of treatment success. These results could be applied to clinical practice before external validation of our nomogram.

Sexual Rehabilitation After Nerve-Sparing Radical Prostatectomy: Free-of-Charge Phosphodiesterase Type 5 Inhibitor Administration Improves Compliance to Treatment.

BACKGROUND: In December 2006, the region of Tuscany (Italy) authorized the free-of-charge provision of phosphodiesterase type 5 inhibitors (PDE5I) for all patients with Tuscan citizenship who undergo nerve-sparing radical prostatectomy (NSRP). OBJECTIVE: To compare sexual rehabilitation outcomes in patients with low risk of erectile dysfunction and minimal comorbidities who received PDE5Is free of charge (PDE5I-F) with those who paid for PDE5Is (PDE5I-P) after bilateral NSRP. METHODS: We reviewed prospectively recorded clinical data of 2,368 patients with Tuscan (PDE5I-F) and non-Tuscan (PDE5I-P) citizenship treated with NSRP at 3 different institutions in Tuscany from 2008 to 2013. Inclusion criteria for the final analysis were open or robot-assisted bilateral NSRP; low risk of postoperative erectile dysfunction according to the Briganti risk stratification tool; no smoking and no drug and alcohol abuse; no cardiovascular risk factors; no major surgery before and after NSRP; no neoadjuvant or adjuvant treatment; and no biochemical relapse. Dropout was defined as an interruption longer than 40 days of the treatment protocol indicated in the inclusion criteria. Treatment compliance was defined as more than 90% consumption of the prescribed PDE5I. OUTCOMES: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the Italian version of the University of California-Los Angeles Prostate Cancer Index sexual function (UCLA-PCI-s) questionnaires were administered to assess patients' satisfaction with PDE5I treatment and sexual function. RESULTS: Overall, 648 patients in the PDE5I-F group and 182 in the PDE5I-P group met the inclusion criteria and were eligible for the study. Patients had comparable preoperative and surgical characteristics. The PDE5I-F group had a significantly higher early rehabilitation onset (P < .001), lower treatment dropout at 12, 24, and 36 months (P < .001 for all comparisons), and higher compliance to the treatment protocol at 6 and 12 months (P = .01 and P < .001, respectively). At multivariable analysis, the PDE5I-F protocol was an independent predictor of an EDITS score higher than 50 (hazard ratio = 1.54, P = .03) and a UCLA-PCI-s score higher than 50 (hazard ratio = 3.12, P = .01) after adjusting for the effects of several clinical features. CLINICAL IMPLICATIONS: The free-of-charge protocol has a significant impact on patients' satisfaction with PDE5I treatment. STRENGTHS AND LIMITATIONS: To our knowledge, this is the first study comparing free vs paid access to a sexual rehabilitation protocol. Major limitations are the observational nature of the study and the different population sizes of the 2 groups. CONCLUSIONS: In a selected cohort of patients after NSRP, free-of-charge access to a sexual rehabilitation protocol was significantly associated with higher early rehabilitation onset, major compliance to the protocol, minor treatment dropout, and higher satisfaction rate of patients. Siena G, Mari A, Canale A, et al. Sexual Rehabilitation After Nerve-Sparing Radical Prostatectomy: Free-of-Charge Phosphodiesterase Type 5 Inhibitor Administration Improves Compliance to Treatment. J Sex Med 2018;15:120-123.

Sildenafil 25 mg ODT + Collagenase Clostridium hystoliticum vs Collagenase Clostridium hystoliticum Alone for the Management of Peyronie's Disease: A Matched-Pair Comparison Analysis.

INTRODUCTION: The effectiveness of phosphodiesterase type 5 (PDE5) inhibitors over the conservative management of Peyronie's disease (PD) has been widely questioned. AIM: To determine the role of sildenafil 25 mg film formulation twice a day (S25 b.i.d.) in the improvement of curvature after treatment of collagenase of Clostridium hystoliticum (CCH) in penile curvature owing to PD. METHODS: From April 2017 to April 2018, 161 consecutive patients were treated with S25 b.i.d. + CCH or CCH alone. Adjustment variables consisted of age, penile curvature, and the 15-question International Index of Erectile Function (IIEF-15) questionnaire at baseline using 1:1 propensity-score matching. Overall, 50 patients were considered subdivided into the following: 25 patients who received S25 b.i.d. + CCH (group A) and 25 who received CCH alone (group B). Patients received CCH injection using a shortened protocol and vacuum device in both groups. MAIN OUTCOME MEASURE: The primary outcome of the study was the change in penile curvature after treatment, and secondary outcomes were the change in sexual function (IIEF-15) and in the Peyronie's Disease Questionnaire (PDQ) and its subscores, PDQ-PS (psychosexual symptoms), PDQ-PP (penile pain), and PDQ-SB (symptom bother). RESULTS: Overall, mean penile curvature was 47.0° (SD 21.88), the mean IIEF-EF (erectile function) was 23.56 (SD 4.10), and the mean PDQ was 27.06 (SD 13.55). After the treatment, we observed a mean change for penile curvature of 25.6 (SD 9.05) in group A and -25.6 (SD 9.7) in group B (P < .01), for IIEF-EF of 2.28 (SD 2.33) in group A and 1.36 (SD 1.77) in group B (P = .03), for PDQ-PS of -3.04 (SD 2.95) in group A and of -2.12 (SD 2.06) in group B (P = .11), for PDQ-PP of -1.0 (SD 4.48) in group A and of -0.88 (SD 2.04) in group B (P = .60), for PDQ-SB of -5.84 (SD 4.58) in group A and of -4.16 (SD 4.45) in group B (P = .60), and for Female Sexual Function Index of 3.8 (SD 2.45) in group A and of 2.72 (SD 2.28) in group B (P = .14). We found a rate of global satisfaction of 70.83% in group A and of 84.0% in group B (P = .27). CLINICAL IMPLICATIONS: Addition of S25 b.i.d. to CCH is superior to CCH alone for improving penile curvature and erectile function. STRENGTH & LIMITATIONS: This is the first study comparing sildenafil + CCH vs CCH alone for the treatment of PD. Lack of randomization and direct verification of appropriate use of penile modeling could be considered limitations. CONCLUSION: In this study, combination therapy was superior in terms of penile curvature and erectile dysfunction improvement. Cocci A, Cito G, Urzì D, et al. Sildenafil 25 mg ODT + collagenase Clostridium hystoliticum vs collagenase Clostridium hystoliticum alone for the management of Peyronie's disease: A matched-pair comparison analysis. J Sex Med 2018;15:1472-1477.

Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study.

BACKGROUND: Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD). AIM: To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners' bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center. METHODS: All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections. OUTCOMES: International Index of Erectile Function (IIEF)-15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment. RESULTS: Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33%) partners showed a degree of sexual dysfunction. Baseline median IIEF-15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF-total and all domains significantly improved after treatment (all P < .01). A PC mean change of 19.07 (P = .00) was measured. At the univariate linear regression analysis, IIEF-15, IIEF-erectile function, IIEF-sexual desire, and IIEF-intercourse satisfaction were positively associated with FSFI (all P ≤ .03); conversely, PDQ-penile pain, PDQ-symptom bother, and post-treament penile curvature (P ≤ .04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95% CI 0.02-0.11; P = .004). Global satisfaction after treatment was 89.6% (121/135). CLINICAL TRANSLATION: This modified CCH treatment protocol could improve both patients' and partner's sexual function. STRENGTH AND LIMITATIONS: This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account. CONCLUSIONS: The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients' and partners' sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716-721.

Effectiveness and Safety of Oro-Dispersible Sildenafil in a New Film Formulation for the Treatment of Erectile Dysfunction: Comparison Between Sildenafil 100-mg Film-Coated Tablet and 75-mg Oro-Dispersible Film.

BACKGROUND: A new oro-dispersible film (ODF) formulation of sildenafil has been developed for the treatment of erectile dysfunction (ED) to overcome the drawbacks that some patients experience when taking the conventional film-coated tablet (FCT). AIM: To assess the effectiveness and safety of sildenafil ODF formulation in patients with ED who were using the conventional FCT. METHODS: From May 2017 through July 2017, 139 patients with ED were enrolled. Data from penile color-duplex ultrasound, medical history, hormonal evaluation, and patient self-administered questionnaires were collected. All patients were administered sildenafil 100-mg FCT for 4 weeks. Thereafter, they underwent a 2-week washout period and subsequently took sildenafil 75-mg ODF for 4 weeks. OUTCOMES: The International Index of Erectile Function (IIEF-15), Hospital Anxiety and Depression Scale (HADS), Patient Global Impressions of Improvement (PGI-I), and Clinician Global Impressions of Improvement (CGI-I) questionnaires were administered and severity of ED was classified as severe (IIEF-15 score ≤ 10), moderate (IIEF-15 score 11-16), or mild (IIEF-15 score = 17-25). RESULTS: All patients completed the final protocol. Differences in mean IIEF scores for erectile function, orgasmic function, sexual desire, and intercourse satisfaction were significantly in favor of sildenafil 100-mg FCT, whereas the mean score for overall satisfaction was in favor of sildenafil 75-mg ODF. A significant difference in changes in HADS score was found from washout to final follow-up (mean difference = -0.19; P < .01). For the ODF formulation, the median CGI-I score was 3.5 (interquartile range [IQR] = 2.5-4.5) and the median PGI-I score was 3.0 (IQR = 2.0-4.0). The median action time was 20.0 minutes (IQR = 15.0-30.0) and the median mouth time was 60.0 seconds (IQR = 30.0-120.0). CLINICAL IMPLICATIONS: The ODF formulation of a widely known drug, with the same safety and effectiveness of the FCT, was better appreciated by patients in overall satisfaction. STRENGTHS AND LIMITATIONS: This is the first clinical trial to assess the efficacy of a new formulation of sildenafil in patients with ED. The limitations of the study are related to the methodology used: it was not a case-control study and the patients were not drug-naïve for ED treatment. Therefore, only the "additional" side effects of the ODF formulation compared with FCT are reported. CONCLUSION: The new ODF formulation is as efficient and safe as the FCT formulation and offers a new choice of treatment to specialists for more precisely tailored therapy. Cocci A, Capece M, Cito G, et al. Effectiveness and Safety of Oro-Dispersible Sildenafil in a New Film Formulation for the Treatment of Erectile Dysfunction: Comparison Between Sildenafil 100-mg Film-Coated Tablet and 75-mg Oro-Dispersible Film. J Sex Med 2017;14:1606-1611.

A combination of tryptophan, Satureja montana, Tribulus terrestris, Phyllanthus emblica extracts is able to improve sexual quality of life in patient with premature ejaculation.

OBJECTIVE: The management of patient affected by premature ejaculation (PE) is nowadays not highly satisfactory. Here, we aimed to evaluate the tolerability and efficacy of a combination of tryptophan, Satureja montana, Tribulus terrestris, Phyllanthus emblica extracts in order to improve sexual quality of life in patients with premature ejaculation. MATERIALS AND METHODS: All patients attending to 5 urological centers from January 2015 to March 2015, due to premature ejaculation were enrolled in this study. At the enrolment visit, all subjects underwent self-administered IIEF-5, Male Sexual Health Questionnaire-Ejaculation Disorder (MSHQEjD), PEDT and IELTS (calculated as mean from that perceived by partner and that perceived by patient) and underwent urological visit and laboratory examinations. All patients received one tablet per day of a combination of tryptophan, Satureja montana, Tribulus terrestris, Phyllanthus emblica extracts for 3 months (Group A). After 3 months all patients underwent follow-up visit with the same investigations that have been carried out in the enrolment visit. The results were compared with a cohort of patients enrolled in the same period in another urological center and considered as a control group (Group B). All patients in the control group underwent counseling and sexual behavioral treatment without any pharmacological compound. RESULTS: At the follow-up analysis, significant changes in terms of IELT in the Group A (mean difference: 31.90; p < 0.05) at 3 months and versus Group B at the intergroup analysis (mean difference: 30.30; p < 0.05) were reported. In the group A, significant differences from baseline to last follow- up were observed relative to IIEF-5 (mean difference: 1.04; p < 0.05), PEDT (mean difference: -2.57; p < 0.05) and FSH (mean difference: -16.46; p < 0.05). CONCLUSION: In conclusion, patients affected by PE may significantly benefit from oral therapy with a combination of tryptophan, Satureja montana, Tribulus terrestris, Phyllanthus emblica extracts in terms of IELT and PEDT scores improvement.

INSIST-ED: Italian Society of Andrology registry on penile prosthesis surgery. First data analysis.

OBJECTIVES: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. MATERIAL AND METHODS: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. RESULTS: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). CONCLUSIONS: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.

Androgen deprivation therapy (castration therapy) and pedophilia: What's new.

Andrology is a constantly evolving discipline, embracing social problems like pedophilia and its pharmacological treatment. With regard to chemical castration, the andrologist may perform an important role as part of a team of specialists. At present, no knowledge is available regarding hormonal, chromosomal or genetic alterations involved in pedophilia. International legislation primarily aims to defend childhood, but does not provide for compulsory treatment. We reviewed international literature that, at present, only comprises a few reports on research concerning androgen deprivation. Most of these refer to the use of leuprolide acetate, rather than medroxyprogesterone and cyproterone acetate, which present a larger number of side effects. Current opinions on chemical castration for pedophilia are discordant. Some surveys confirm that therapy reduces sexual thoughts and fantasies, especially in recidivism. On the other hand, some authors report that chemical castration does not modify the pedophile's personality. In our opinion, once existing legislation has changed, andrologists could play a significant role in the selection of patients to receive androgen deprivation therapy, due in part to their knowledge about its action and side effects.

Effect of human papillomavirus and Chlamydia trachomatis co-infection on sperm quality in young heterosexual men with chronic prostatitis-related symptoms.

OBJECTIVE: To investigate the effect of human papillomavirus (HPV) and Chlamydia trachomatis (Ct) co-infection on sperm concentration, motility and morphology, in a large cohort of young heterosexual male patients with chronic prostatitis-related symptoms. PATIENTS AND METHODS: Patients with chronic prostatitis-related symptoms, attending the same centre for sexually transmitted diseases from January 2005 and December 2010, were consecutively enrolled in this cross-sectional study. All patients underwent clinical and instrumental examination, microbiological cultures for common bacteria, DNA extraction, mucosal and serum antibodies evaluation for Ct, specific tests for HPV and semen analysis. The semen variables analysed were: volume; pH; sperm concentration; motility; and morphology. Subjects were subdivided in two groups: group A, patients with Ct infection alone and group B, patients with Ct and HPV co-infection. The main outcome measurement was the effect of Ct and HPV co-infection on the semen variables examined. RESULTS: Of 3050 screened patients, 1003 were enrolled (32.9%) in the study. A total of 716 (71.3%) patients were allocated to group A, and 287 (28.7%) to group B. Significant differences between the two groups were reported in terms of percentage of motile sperm (degrees of freedom [df] = 1001; t-test = 11.85; P < 0.001) and percentage of normal morphological forms (df = 1001; t-test = 7.18; P < 0.001), while no differences were reported in terms of semen volume or pH. According to World Health Organization thresholds for normal semen, 364 (50.8%) men in group A and 192 (66.8%) men in group B were subfertile (odds ratio = 1.95; 95% confidence interval 1.46-2.60; P < 0.001). No correlation between HPV genotype, mucosal IgA type and semen variables was found. CONCLUSION: In a population of prostatitis-related symptoms attributable to Ct infection, co-infection with HPV has a significant role in decreasing male fertility, in particular with regard to sperm motility and morphology.

Chlamydia†trachomatis infection is related to premature ejaculation in chronic prostatitis patients: results from a cross-sectional study.

INTRODUCTION: Chronic bacterial prostatitis (CBP) is reported to be a common finding in men with acquired premature ejaculation (PE). The impact of different pathogens on PE development in chronic prostatitis patients is, however, unknown. AIM: To assess a possible link between CBP caused by Chlamydia trachomatis (Ct) and PE. METHODS: A consecutive series of 317 patients with clinical and instrumental diagnosis of CBP due to Ct was enrolled (group A) and compared with data obtained from a control group of 639 patients with CBP caused by common uropathogen bacteria (group B). Prostatitis symptoms were investigated with the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), while the ejaculatory status of patients was assessed using the PE Diagnostic Tool (PEDT). MAIN OUTCOME MEASURES: All participants were asked to complete the NIH-CPSI, the International Index of Erectile Function-15 erectile function domain (IIEF-15-EFD), the PEDT, and the Short Form (SF)-36 questionnaires. RESULTS: Patient groups A and B had comparable scores of NIH-CPSI (P = 0.07), IPSS (P = 0.32), and IIEF-15-EFD (P = 0.33) tests. PE was assessed in 118 patients in group A (37.2%) and in 73 subjects in group B (11.5%). The two groups are different in terms of PE prevalence (P < 0.0002). Compared with group B, group A showed significantly higher scores of the PEDT test (11.3 [±2.6] vs. 4.5 [±2.9], P < 0.0001) and lower scores of the SF-36 tool (96.5 [±1.1] vs. 99.7 [±1.3], P < 0.0001). In our multivariate model assessment, being positive for a Ct infection marker was independently associated with the PEDT score even after adjusting for age, smoking habit, body mass index, and education level (adjusted odds ratio = 3.21; 95% confidence interval: 2.02-4.27; P < 0.003). CONCLUSIONS: Patients affected by CBP due to Ct infection reported higher prevalence of PE and lower quality of life when compared with patients affected by CBP caused by traditional uropathogenic bacteria.

Apple consumption is related to better sexual quality of life in young women.

INTRODUCTION: Even if some evidence exists of a positive correlation between regular intake of phytoestrogens, polyphenols, antioxidants and women's sexual health, there is not a study addressing the potential correlation between daily apple consumption and women's sexual function. We aim to assess whether there is a tie between daily apple intake and sexual function in a sample of healthy young sexually active Italian women, not complaining of any sexual disorders. MATERIALS AND METHODS: Seven hundred and thirty-one women (mean age 31.9, range 18-43) were enrolled in this cross-sectional study (from September 2011 to April 2012). All participants completed anonymously the Female Sexual Function Index (FSFI) and were asked to report on their amount of daily apple consumption and their eating habits. On the basis of apple consumption all women were split into two groups: Group A--regular daily apple consumption, Group B--no regular apple consumption (<1 apple/day). The main outcome measure was the FSFI questionnaire result. RESULTS: Three hundred and forty-three women reported a regular daily apple intake and were classified in Group A, while 388 were included in Group B. Group A had a significantly higher total (p = 0.001; Cohen's d = 3.39) and lubrication domain (p = 0.001; Cohen's d = 3.02) FSFI scores than participants in Group B. Multivariate analysis demonstrated that daily apple intake must be considered as an independent parameter (p = 0.002) in predicting a better score at questionnaire examination. DISCUSSION: This study suggests a potential relationship between regular daily apple consumption and better sexuality in our young women population.

Human papillomavirus infection is not related with prostatitis-related symptoms: results from a case-control study.

PURPOSE: To investigate the relationship between human papillomavirus (HPV) infection and prostatitis-related symptoms. MATERIALS AND METHODS: All young heterosexual patients with prostatitis-related symptoms attending the same Center from January 2005 to December 2010 were eligible for this case-control study. Sexually active asymptomatic men were considered as the control group. All subjects underwent clinical examination, Meares-Stamey test and DNA-HPV test. Patients with prostatitis-related symptoms and asymptomatic men were compared in terms of HPV prevalence. Moreover, multivariable Cox proportional hazards regression analysis was performed to determine the association between HPV infection and prostatitis-related symptoms. RESULTS: Overall, 814 out of 2,938 patients (27.7%) and 292 out of 1,081 controls (27.0%) proved positive to HPV. The HPV genotype distribution was as follows: HR-HPV 478 (43.3%), PHR-HPV 77 (6.9%), LR-HPV 187 (16.9%) and PNG-HPV 364 (32.9%). The most common HPV genotypes were: 6, 11, 16, 26, 51, 53 and 81. No difference was found between the two groups in terms of HPV infection (OR 1.03; 95% CI 0.88-1.22; p = 0.66). We noted a statistically significant increase in HPV infection over the period 2005 to 2010 (p < 0.001) in both groups. Moreover, we found a statistically significant increase in HPV 16 frequency from 2005 to 2010 (p = 0.002). CONCLUSIONS: This study highlights that prostatitis-like symptoms are unrelated to HPV infection. Secondary, we highlight the high prevalence of asymptomatic HPV infection among young heterosexual men.

Clinical utility of an undersized nurse-operated recovery room in the postoperative course: results from an Italian community setting.

PURPOSE: In Europe, standardized criteria for recovery room (RR) requirements have not been established. The purpose of this study was to examine the clinical utility of an undersized nurse-operated RR in an Italian community hospital. DESIGN: Single-center observational study. METHODS: A total of 1,945 consecutive surgical patients admitted to the RR at the study institution between September 31, 2009, and August 31, 2011, were included in the study. A control group of surgical patients not admitted to the RR, matched for age, gender, American Society of Anesthesiologists score, and type of surgery were also considered. The prevalence of early adverse events occurring within 3 hours of the end of surgery was compared between the two groups. FINDINGS: Patients admitted to the RR (mean age, 73.6 ± 14.2 years; 42.2% male; and 76.3% having major surgery) showed lower prevalences of hypotension (P < .0001), hypertensive response (P < .0001), new arrhythmias requiring intervention (P = .0036), and oxygen desaturation (P < .0001) in comparison with the control group. No differences in the proportions of patients experiencing postoperative nausea and vomiting, shivering, bleeding, and respiratory events were found. The Numeric Rating Scale for pain was also significantly lower at 2 hours in the study group as compared to the control group (1 [0 to 5] vs 3 [1 to 7]; P < .0001). CONCLUSION: In this Italian community setting, an undersized nurse-operated RR contributed to a reduced prevalence of adverse postoperative events.

Penile prosthesis surgery in out-patient setting: Effectiveness and costs in the "spending review" era.

INTRODUCTION: Penile implant patients are required to remain in the hospital after the operation for monitoring, antibiotic and analgesia administration. Cost containment, however, has resulted in the increased use of ambulatory surgery settings for many surgical procedures. Few studies have studied the feasibility of performing penile prosthesis insertion in an outpatient setting. The results are controversial and nowadays, in the most of centers that deal with prosthetic surgery, patients are still hospitalized. AIM: The aim of our investigation was to compare the feasibility of the performance as well as the complication profiles of penile implant surgery performed in an in-patient and an outpatient setting at a single center by a single surgeon. METHODS: From January 2009 to June 2014, 50 patients of the same uro-andrological unit underwent penile prosthesis implantation performed by a single surgeon (N.M.). Twenty implantations were performed in an ambulatory day surgery setting. MAIN OUTCOME MEASURES: Effectiveness and costs of outpatient setting versus the in-patient setting of the penile prosthesis surgery. RESULTS: There were some differences between the two groups in the intra-operative parameters, such as, operating time. Time lost from work was similar in both groups approximating 14 days. The mean number of analgesic pills ingested by the patients post-operatively was similar in both groups, averaging just under 25 pills per patient. There weren't post-operative complications in the outpatient group. Cost were 17% less in outpatient clinic. CONCLUSIONS: The outpatient setting for this surgery is safe and effective even in patients with comorbidities or in case of secondary procedures. Costs are reduced by 17%.

Efficacy and safety of two disposable circumcision suture devices for circumcision in adults: a prospective comparative multicenter study.

The objective of this study was to evaluate and compare efficacy and safety of two different Disposable circumcision suture devices (DCSDs). A prospective comparative non-randomized multicenter study was performed between November 2019 and February 2023. Patients underwent circumcision using a DCSD (CircCurerTM or the ZSR® device) according to the surgeon preference and device availability. A total of 378 patients were circumcised; 184 using CircCurerTM and 194 patients using ZSR®. No differences in baseline characteristics were observed. CircCurer and ZSR Groups showed similar rates of operative time (7.7 ±2.1 vs 7.3 ±2.0 min), surgical site infection (1.1% Vs 1.5%), edema (13% Vs 8.2%), hematomas (2.7% Vs 1.1%), and postoperative pain (2.5 Vs 2.0 points). ZSR Group had a significantly higher rate of clip fallout (62.9% Vs 38%, p < 0.001). At 2 months, patients of both groups reported a median satisfaction of 9 (8-9) points. Main limitation consist in non-randomized study. DCSDs seem to be effective and safe, with short operative times, uncommon and mild complications, and high patient satisfaction. ZSR® device has a higher rate of spontaneous staple dropout.

The role of chronic prostatic inflammation in the pathogenesis and progression of benign prostatic hyperplasia (BPH).

Several different stimuli may induce chronic prostatic inflammation, which in turn would lead to tissue damage and continuous wound healing, thus contributing to prostatic enlargement. Patients with chronic inflammation and benign prostatic hyperplasia (BPH) have been shown to have larger prostate volumes, more severe lower urinary tract symptoms (LUTS) and a higher probability of acute urinary retention than their counterparts without inflammation. Chronic inflammation could be a predictor of poor response to BPH medical treatment. Thus, the ability to identify patients with chronic inflammation would be crucial to prevent BPH progression and develop target therapies. Although the histological examination of prostatic tissue remains the only available method to diagnose chronic inflammation, different parameters, such as prostatic calcifications, prostate volume, LUTS severity, storage and prostatitis-like symptoms, poor response to medical therapies and urinary biomarkers, have been shown to be correlated with chronic inflammation. The identification of patients with BPH and chronic inflammation might be crucial in order to develop target therapies to prevent BPH progression. In this context, clinical, imaging and laboratory parameters might be used alone or in combination to identify patients that harbour chronic prostatic inflammation.

Genital diseases awareness in young male students: Is information necessary to protect them?

INTRODUCTION: Few studies on the prevalence of male sexual diseases are currently available due to difficult application of observational studies or andrological disease prevention campaigns on large series of apparently healthy subjects. The medical check-up linked to compulsory military service represented in Italy a valid tool for epidemiological and observational study for 18 year old boys from 1861 to 2004. The stopping of compulsory military service and its related medical check-up could have determined an important social impact in terms of a lower level of attention and care on male genital/sexual diseases. The aim of the present observational study was to check the prevalence of genital/sexual diseases among young male high-school students and promote an alternative campaign of information among young students. METHODS: A prospective observational analytical study on young male students was conducted by 6 urological centres. Genital and sexually transmitted diseases were presented with slides to students in a general assembly. Some students were then counselled and filled out a short questionnaire on their lifestyle. RESULTS: 12,535 students (10,432 males-83.6%) followed the presentation. and 4,897 males (46.7%) decided to be checked-up by the urologist and out of them 1554 (31.7%) presented relevant andrological diseases. Five-hundred students completed the questionnaire concerning their lifestyle. Many of them had not yet experienced condom use during sexual intercourse (27.8%). Drug abuse was reported by 39.6% of subjects and alcohol consumption in 80.8% of them. CONCLUSIONS: These data suggest the need for a national information campaign on male sexual disorders to promote sexual health.