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BackgroundWhile premature ejaculation (PE) is a common and disturbing sexual dysfunction in men, current available treatment modalities have limited efficacy and low treatment adherence.AimTo assess the feasibility, safety, and efficacy of the vPatch, a miniaturized on-demand perineal transcutaneous electrical stimulation device for treating PE.MethodsThis 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.OutcomesOutcomes included changes in IELT and Premature Ejaculation Profile before and after treatment, last visit Clinical Global Impression of Change scores, and vPatch safety profile.ResultsOf 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 Clinical ImplicationsTherapeutic use of the vPatch during coitus may become an on-demand, noninvasive, and drug-free treatment for PE.Strengths and LimitationsTo 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.ConclusionWe 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).

Introduction: Andrological emergencies include a wide array of acute genital injuries which require immediate care from the specialist. Missing or delaying treatment often results in permanent loss of function or, in some cases, loss of the affected organ itself.Evidence acquisition: A comprehensive bibliographic search of PubMed database with up-to-date existing reviews and case reports was performed.Objective: This chapter aims to review major andrological emergencies with peculiar attention to clinical presentation and practical management in order to provide the specialist with reliable information to keep in mind when confronting these challenging occurrences.

BackgroundHyaluronic acid (HA) has demonstrated clinical benefits for the treatment of Peyronie’s disease (PD); however, there are no reports that documented long-term outcomes. The aim of the current study is to illustrate the clinical outcomes after 2 years of follow-up in patients who received HA for PD.MethodsFrom January 2015 to December 2018, we enrolled 244 patients affected by PD in this multicenter non-randomized clinical study, as previously reported. Patients received intralesional HA (Group A) or verapamil (Group B). Follow-up was undertaken after 3 months, 1 year, and 2 years. International Index of Erectile Function (IIEF-5), PC, and visual analogue scale (VAS) were collected.ResultsAmong the whole cohort, 125 patients were included in Group A and 119 in Group B. As PC, the median curvature was 25.0° at 3 months [interquartile range (IQR), 15.0–30.0] (p=0.45) and was maintained at 1 (p=0.87) and 2 years of follow-up (p=0.90) (Group A), while it was 30.0° (IQR, 20.0–35.0) (p=0.67) at 3 months and was stable at 1 (p=0.77) and 2 years of follow-up (p=0.80) (Group B). For VAS score, the median change in Group A was −4.0 (IQR, −4.0, −5.0, pConclusionsWe reported clinical efficacy of intralesional HA in patients with PD after 2 years of follow-up by slightly improving penile curvature (PC) and bother of the disease. These results should be considered during the counseling of the patients especially regarding the lack of worsening over time.

Radical prostatectomy (RP) represents one of the most commonly used first-line treatment modalities in men with localized prostate cancer (PCa). Despite efforts to preserve the neurovascular bundles with nerve sparing (NS) surgery, erectile dysfunction (ED) remains common after RP and this may significantly affect patients' quality of life (QoL). The aim of this paper is to evaluate the outcome of simultaneous placement of penile prosthesis and RP. The ideal candidates for simultaneous penile prosthesis implantation are those who report pre-existent refractory ED and patients in whom there is a high risk of extracapsular disease, such as any cT2c or cT3, and undergo non-nerve sparing RP. If the patient chooses to undergo PPI to treat his refractory ED it is clear that this procedure will be associated with higher patients' satisfaction rates, if carried out simultaneously with RP rather than at a later stage. A simultaneous procedure would avoid two admissions, reduce hospitalization time and guarantee a faster recovery of sexual function, preventing the otherwise unavoidable loss of penile length. Since the urologist does not need to preserve the neurovascular bundles, as the penile implant will take care of postoperative rigidity, RP can be performed more radically from an oncological point of view, thus reducing the risk of recurrence and metastasis, especially in patients with high risk of locally advanced disease. In conclusion, simultaneous PPI with RP provides early sexual rehabilitation, improving patients' quality of life, without compromising surgical outcomes. However, larger series will be necessary, to better identify the patients who are more likely to benefit from nerve sparing surgery and postoperative penile rehabilitation from those who would are more likely to develop refractory ED post RP and would therefore benefit from simultaneous implantation of a penile prosthesis.

BACKGROUND AND OBJECTIVE: Plaque formation ordinarily takes place in the acute phase of Peyronie's disease. There is no unanimous consent regarding the management of the acute phase of Peyronie's disease. The objective of this study was to evaluate the advantages of using a single intralesional injection of collagenase Clostridium histolyticum in patients with the active phase of Peyronie's disease and to assess its effect on disease progression by reducing penile curvature and ameliorating pain during sexual intercourse.Sexually active men aged older than 18 years with the acute phase of Peyronie's disease were enrolled. All patients received treatment with a single intralesional injection of collagenase Clostridium histolyticum. The primary outcome of the study was the change in penile curvature after treatment while secondary outcomes were the change in sexual function (International Index of Erectile Function [IIEF-5]) and in the Peyronie Disease Questionnaire (PDQ) and its sub-scores, PDQ-PS (psychological symptoms), PDQ-PP (penile pain) and PDQ-BD (bother disease).Overall, 74 patients were enrolled. Mean penile curvature at baseline was 41.1° ± 12.2°. The mean changes before and at the 3-month evaluation in terms of penile curvature, Visual Analog Scale score at rest, and Visual Analog Scale score during intercourse were - 19.3 ± 8.4 (p 0.0001), - 0.8 ± 1.1 (p 0.0001) and - 3.8 ± 0.9 (p 0.0001) with the benefit persisting also after 6 months. Moreover, improvements of mean IIEF-5 score (1.1 ± 0.9, p = 0.03; 0.9 ± 0.5, p = 0.02), PDQ-PS (- 2.7 ± 2.2; - 2.5 ± 2.0, p = 0.01), PDQ-PP (- 1.2 ± 1.6; - 1.1 ± 1.2, p = 0.02) and PDQ-BD (- 3.8 ± 3.4; - 3.5 ± 3.1, p = 0.001) were observed 3 and 6 months after the end of treatment, respectively. At the multivariable regression analysis, the time since disease onset (modelled with non-linear terms) and baseline curvature were independently associated with the degree of curvature improvement (coefficient: 0.30; 95% confidence interval 0.16-0.44) after a single intralesional injection (all p 0.03).Although intralesional therapy with collagenase Clostridium histolyticum is not yet indicated for the acute phase of Peyronie's disease, these preliminary results suggest the effectiveness of this minimally invasive option by improving penile curvature and IIEF-5 and PDQ scores.

To investigate the efficacy, tolerability, and patient’s preference of alprostadil cream for topical use administered within the urethral meatus versus the standard administration route, in erectile dysfunction (ED) treatment. Seventy-one patients (mean age 59.7 ± 9.0 years) affected by ED were analyzed in this multicenter, randomized, two-administration routes, cross-over trial. All patients received a single dose of alprostadil cream applying the dispenser to the tip of the penis (without contacting the urethral meatus) (Standard administration route or ST.AR) alternating with a single dose of alprostadil cream applying the dispenser within the urethral meatus (New administration route or NEW.AR) separated by a one-week washout period, according to randomization. The primary objective of the study was to evaluate the change in International Index of Erectile Function (IIEF-5) total score from baseline to the control visit by comparing the ST.AR and NEW.AR. Secondary objectives of the study were to compare the different methods of administration by evaluating the change in the Sexual Encounter Profile (SEP-2 and SEP-3) questionnaire score and the Patient Reported Outcomes (PROs) by scoring the Patient Self- Assessment of Erection (PSAE) questionnaire. The treatment safety profile was assessed by analysis of adverse events (AEs). Based on the study findings it is evident that the NEW.AR is more efficacious than the ST.AR in improving IIEF-5 and SEP scores from baseline to control visit (IIEF-5: +3.8 vs +6.3; p < 0.001; positive response to SEP-2: 10 vs 27; p = 0.002) and in terms of PSAE (a significant improvement from the baseline in 31% of patients; p < 0.001). As regards the safety profile, no difference in terms of local and systemic side effects was found.

Peyronie's disease (PD) is a common condition which results in penile curvature making sexual intercourse difficult or impossible. Collagenase clostridium histolyticum (CCH) is the first licensed drug for the treatment of PD and is indicated in patients with palpable plaque and curvature deformity of at least 30° of curvature. However, only few monocentric studies are available in the current literature and this is the first national multicentric study focusing on this new treatment. In five Italian centres, 135 patients have completed the treatment with three injections of CCH using Ralph's shortened modified protocol. The protocol consisted of three intralesional injections of CCH (0.9 mg) given at 4-weekly intervals in addiction to a combination of home modelling, stretching and a vacuum device on a daily basis. An improvement in the angle of curvature was recorded in 128/135 patients (94.8%) by a mean (range) of 19.1 (0–40)° or 42.9 (0–67)% from baseline (p

Background andObjective: Plaque formation ordinarily takes place in the acute phaseof Peyronie’s disease. There is no unanimous consent regarding the management of the acute phase ofPeyronie’s disease.The objective of this study was to evaluate the advantages of using a single intralesional injection of collagenase Clostridium histolyticum in patients with the active phase of Peyronie’s disease and to assess its effect on disease progression by reducing penile curvature and ameliorating pain during sexual intercourse. Methods: Sexually active men aged older than 18years with the acute phase of Peyronie’s disease were enrolled. All patients received treatment with a single intralesional injection of collagenase Clostridium histolyticum. The primary outcome of the study was the change in penile curvature after treatment while secondary outcomes were the change in sexual function (International Index of Erectile Function [IIEF-5]) and in the Peyronie Disease Questionnaire (PDQ) and its sub-scores, PDQ-PS (psychological symptoms), PDQ-PP (penile pain) and PDQ-BD (bother disease). Results: Overall, 74 patients were enrolled. Mean penile curvature at baseline was 41.1° ± 12.2°. The mean changes before and at the 3-month evaluation in terms of penile curvature, Visual Analog Scale score at rest, and Visual Analog Scale score during intercourse were − 19.3 ± 8.4 (p < 0.0001), − 0.8 ± 1.1 (p < 0.0001) and − 3.8 ± 0.9 (p < 0.0001) with the benefit persisting also after 6months. Moreover, improvements of mean IIEF-5 score (1.1 ± 0.9, p = 0.03; 0.9 ± 0.5, p = 0.02), PDQ-PS (− 2.7 ± 2.2; − 2.5 ± 2.0, p = 0.01), PDQ-PP (− 1.2 ± 1.6; − 1.1 ± 1.2, p = 0.02) and PDQ-BD (− 3.8 ± 3.4; − 3.5 ± 3.1, p = 0.001) were observed 3 and 6months after the end of treatment, respectively. At the multivariable regression analysis, the time since disease onset (modelled with non-linear terms) and baseline curvature were independently associated with the degree of curvature improvement (coefficient: 0.30; 95% confidence interval 0.16–0.44) after a single intralesional injection (all p < 0.03). Conclusions: Although intralesional therapy with collagenase Clostridium histolyticum is not yet indicated for the acute phase of Peyronie’s disease, thesepreliminary results suggest the effectiveness of this minimally invasive option by improving penile curvature and IIEF-5 and PDQ scores.

INTRODUCTION AND OBJECTIVES:The treatment of chronic pelvic pain syndrome (CPPS) is still discussed since its multifactorial pathogenesis. Several treatment modalities including antimicrobial drugs...

INTRODUCTION AND OBJECTIVES:Patients affected by Peyronie’s disease (PD) benefit most from therapy with Collagenase Clostridium Hystolyticum (CCH). However, clinical results in patients with uncomm...

Purpose The aim of this study was to evaluate the efficacy of collagenase Clostridium histolyticum (CCH) in patients with Peyronie's disease (PD) suffering from atypical deformities. Materials and Methods We retrospectively collected data of patients with atypical penile curvature (PC) secondary to PD. All patients underwent a modified treatment protocol, consisting of 3 intralesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum PC. Patients were instructed to follow a strict routine, involving daily modeling of erect penis and stretching at the urinary toilette time, two minutes each. Success was defined as a decrease in PC of ≥20° from baseline. Results Sixty-five patients were included in the analysis. Median age was 59.0 years (interquartile range [IQR], 53.0 to 63.0 years), median curvature 40.0° (IQR, 30.0° to 45.0°) median duration of the disease 12.0 years (IQR, 6.5 to 24.0 years). Fifty-three patients (81.54%) had ventral PC, 7 (10.77%) hourglass PC, and 5 (7.69%) shortening PC. Median changes of PC were −20.0 (IQR, −20.0 to −10.0; p

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.

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.

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.

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.

Purpose: There are many grey areas in the field of penile rehabilitation after radical prostatectomy (RP). The preservation of the full dimensions of the penis is an important consideration for improving patients’ compliance for the treatment. We present the first case series of patients treated by laparoscopic extraperitoneal RP and simultaneous penile prosthesis implantation (PPI) in order to preserve the full length of the penis and to improve patients’ satisfaction. Materials and Methods: From June 2013 to June 2014, 10 patients underwent simultaneous PPI (with an AMS InhibiZone prosthesis) and RP. Patients were evaluated by means of urological visits, questionnaires, and objective measurements before surgery, at discharge from the hospital, on postoperative days 21 to 28, each 3 months for the first year, and each 6 months thereafter. The main outcome measures were biochemical recurrence-free rate, penile length, and quality of life. Results: Ten patients (mean age of 61 years; completed the study follow-up period (median, 32.2 months). No difference was found between the time of surgery and the 2-year follow-up evaluation in terms of penile length. The pre-surgery 36-Item Short Form Health Survey (SF-36) median score was 97. Patients were satisfied with their penile implants, and couples’ level of sexual satisfaction was rated median 8. The median postoperative SF-36 score was 99 at 3 months follow-up. Conclusions: Laparoscopic extraperitoneal RP surgery with simultaneous PPI placement seems to be an interesting possibility to propose to motivated patients for preserving the length of the penis and improving their satisfaction.