Efficacy of Collagenase Clostridium histolyticum (Xiapex®) in Patients with the Acute Phase of Peyronie's Disease.

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. METHODS: 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). 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 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). CONCLUSIONS: 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.

Systematic review of studies reporting perioperative and functional outcomes following male-to-female gender assignment surgery (MtoF GAS): a call for standardization in data reporting.

INTRODUCTION: The aim of this study is to accomplish a systematic review on the surgical techniques available for male-to-female gender assignment surgery (MtoF GAS) published in the last 15 years, from January 2002 to May 2017, assessing advantages and disadvantages. EVIDENCE ACQUISITION: A specific search on MEDLINE, Scopus and Web of Science databases included vaginoplasty for gender exchange. Preoperative (age, gender, body mass index, prior surgery), intraoperative (mean operating time, intraoperative complications, transfusion rate, conversion rate), postoperative (hospital stays, readmission rate, early and late complication rate), postoperative sexual activity, subjective satisfaction, vaginal depth, and long-term outcomes (vaginal stenosis, prolapse, dyspareunia and labial abscess) data of vaginoplasty for sexual exchange were collected. 29 articles were included (2.402 patients). EVIDENCE SYNTHESIS: Out of the 29 papers, 19 studies assessed penile skin inversion and 10 evaluated intestinal vaginoplasty. No comparative studies were found. Penile skin inversion vaginoplasty reported slightly shorter operative time compared to intestinal vaginoplasty (109-420 vs 145-420 minutes). Intraoperative complications for penile skin inversion vaginoplasty not exceeded an incidence of 10%. No significant differences in terms of postoperative complications or hospitalization time were reported. Intestinal vaginoplasty provides a deeper neovagina. Female Sexual Function Index score was significantly higher in patients undergoing intestinal vaginoplasty. CONCLUSIONS: A standardized data collection may allow a better understanding of effectiveness and outcomes of different techniques.

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.

A Case Series of Patients Who Underwent Laparoscopic Extraperitoneal Radical Prostatectomy with the Simultaneous Implant of a Penile Prosthesis: Focus on Penile Length Preservation.

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.