Functional and Patient Reported Outcomes Following Total Glans Resurfacing.

BACKGROUND: Whilst there is a trend away from aggressive nonorgan sparing surgical treatments for malignant penile disease, a variety of penile preservation options exist but functional outcomes and patient reported outcomes (PROs) in this area are poorly reported to date. AIM: The aim of this study is to report functional outcomes and PROs of total glans resurfacing (TGR) in a consecutive series of patients with lichen sclerosis (LS) or localized penile cancer (PC). METHODS: From 2004 to 2018 a consecutive series of patients underwent TGR for the management of LS or localized PC in a tertiary referral network. Patient clinical records and operative notes were retrospectively reviewed. Statistical analysis was conducted with Stata 12. OUTCOMES: Urinary and sexual outcomes were recorded utilizing both the International Index of Erectile Function (IIEF) and International Prostate Symptom Score (IPSS) validated questionnaires while PROs were extrapolated from a 5-item "ad hoc" telephone questionnaire administered at 1 year post procedure. RESULTS: 37 consecutive patients were enrolled. Histology results demonstrated LS in 16 patients, with the remaining 21 having a diagnosis of PC. The most common reasons for patient presentation were local pain (32.4%), pruritus (37.8%) and bleeding (29.7%). Median follow-up was 22 (IQR 13-77) months. Median age was 62 (IQR 55-68). Neither of the questionnaires assessing urinary and sexual function showed any significant deterioration after surgery. Glans sensitivity was fully maintained in 89.2% of cases. 94.5% of patients reported to be fully satisfied with the aesthetic appearance of the penis and would consider undergoing the same procedure again if necessary. 91.9% of patients would recommend the same procedure to someone else. An overall improvement of the quality of life was reported by 86.4% of patients. CLINICAL IMPLICATIONS: TGR should be considered a treatment of choice for selected cases of benign or malignant penile lesions STRENGTHS AND LIMITATIONS: Our study has some limitations, the first being its retrospective nature. Furthermore, despite being one of the largest series to date, follow-up duration is somewhat limited and a control group is lacking. CONCLUSION: TGR represents an excellent surgical option ensuring satisfactory voiding and sexual function, as well as cosmesis for selected cases of penile lesions. M. Preto, M. Falcone, G. Blecher, et al. Functional and Patient Reported Outcomes Following Total Glans Resurfacing. J Sex Med 2021;18:1099-1103.

Physical, Mental and Sexual Health Among Transgender Women: A Comparative Study Among Operated Transgender and Cisgender Women in a National Tertiary Referral Network.

BACKGROUND: Few studies have investigated how physical, mental and sexual function are associated with each other in operated transgender women (oTW). AIM: To provide information on the physical, mental and sexual health of oTW in comparison with a group of cisgender women (cisW). METHODS: An age-matched control study was carried out, recruiting 125 oTW in 7 national referral centers and 80 volunteer women. Beck Depression Inventory Primary Care (BDI-PC), General Health Survey (SF-36), Female Sexual Function Index (FSFI) and operated Male to Female Sexual Function Index (oMtFSI) questionnaires were web-based administered. Data included: age, area of origin, educational level, sexual orientation, years since surgery and hormone therapy. OUTCOMES: T-test was applied to inspect mean score differences between oTW and cisW, in mental, sexual and physical health; simple correlations and multiple regression analysis revealed how mental, sexual and physical health were concurrently associated in the two groups RESULTS: Response rate 60% (52% oTW, 71% cisW). oTW mean age 38.5 years (SD = 9.3), cisW 37.7 years (SD = 11.5). Both cisW and oTW reported average values in the range of mental, physical and sexual health. Statistical comparisons revealed no significant group differences in mental and physical health. oTW who referred a worse sexual function also reported worse overall mental well-being and higher levels of depressive symptoms. FSFI scores were negatively associated with years since surgery, but not with age. Multiple regression analysis showed that FSFI Pain accounted for a significant unique variance proportion of risk of depression in oTW. FSFI Sexual Pain was the strongest estimator of inter-individual differences in BDI-PC among oTW (P < .01). CLINICAL IMPLICATIONS: No significant differences in the levels of depressive symptoms, physical and mental well- being were found in oTW and cis-W. The relation between depressive symptoms and sexual function in oTW is stronger than in cisW, and sexual pain substantially predicts risk of depression in oTW. STRENGTHS & LIMITATIONS: The evaluation of outcomes using validated questionnaires and the relatively large sample size. The convenience control group reported mental, physical and sexual health levels within the range of Italian normative data. Since this is a cross-sectional study, we must be careful in drawing conclusions from our results. CONCLUSIONS: Sexual pain and lubrication difficulties are the main causes of worse sexual function in oTW, highlighting the importance of perioperative counseling to make surgical expectations realistic and to educate to a proper neovagina management. Vedovo F, Di Blas L, Aretusi F, et al. Physical, Mental and Sexual Health Among Transgender Women. A comparative Study Among Operated Transgender and Cisgender Women in a National Tertiary Referral Network. J Sex Med Rev 2021;18:982-989.

Operated Male-to-Female Sexual Function Index: Validity of the First Questionnaire Developed to Assess Sexual Function after Male-to-Female Gender Affirming Surgery.

PURPOSE: No questionnaire is currently available to evaluate sexual function after male-to-female gender affirming surgery. Such a limit leads to a suboptimal evaluation in postoperative sexual function in these patients. We developed and validated a new questionnaire, the oMtFSFI (operated Male-to-Female Sexual Function Index), for assessing sexual function in male-to-female patients after surgery. MATERIALS AND METHODS: A panel of experts in gender dysphoria defined the main content areas to be assessed, including genital self-image, desire, arousal, lubrication, orgasm, satisfaction and sexual pain. After a pretest on 10 patients the oMtFSFI was applied in the main study to 65 operated male-to-female patients, recruited at 7 Italian centers, and 57 women. The participants provided self-ratings on online oMtFSFI, Female Sexual Function Index, Beck Depression Inventory for Primary Care and Short Form Health Survey questionnaires. Operated male-to-female patients completed the oMtFSFI twice, 4 weeks apart. RESULTS: Principal component analysis performed on self-ratings provided by operated male-to-female patients on oMtFSFI items yielded a 3-domain structure of sexual dissatisfaction, sexual pain and genital self-image. The 3 domains were internally consistent and test-retest reliable. Convergent associations with Female Sexual Function Index scales emerged for sexual dissatisfaction and sexual pain but not for genital self-image. Male-to-female patients reported lower sexual function levels than cisgender women. CONCLUSIONS: The present preliminary results support reliability and psychometric validity of the oMtFSFI in the assessment of key sexual function domains in transgender women, further revealing that genital self-image represents an assessment area to be considered in male-to-female patients, in addition to domains that are salient for cis women as well.

Testis Sparing Surgery of Small Testicular Masses: Retrospective Analysis of a Multicenter Cohort.

PURPOSE: We evaluated possible factors predicting testicular cancer in patients undergoing testis sparing surgery. MATERIALS AND METHODS: We retrospectively analyzed the records of all patients who underwent testis sparing surgery for a small testicular mass at a total of 5 centers. All patients with 1 solitary lesion 2 cm or less on preoperative ultrasound were enrolled in the study. Testis sparing surgery consisted of tumor enucleation for frozen section examination. Immediate radical orchiectomy was performed in all cases of malignancy at frozen section examination but otherwise the testes were spared. Univariate and multivariate analysis were performed and ROC curves were produced to evaluate preoperative factors predicting testicular cancer. RESULTS: Overall 147 patients were included in the study. No patient had elevated serum tumor markers. Overall 21 of the 147 men (14%) presented with testicular cancer. On multivariate analysis the preoperative ultrasound diameter of the lesion was a predictor of malignancy (OR 6.62, 95% CI 2.26-19.39, p=0.01). On ROC analysis lesion diameter had an AUC of 0.75 (95% CI 0.63-0.86, p=0.01) to predict testicular cancer. At the best cutoff of 0.85 the diameter of the lesion had 81% sensitivity, 58% specificity, 24% positive predictive value and 95% negative predictive value. CONCLUSIONS: Our study confirms that small testicular masses are often benign and do not always require radical orchiectomy. Preoperative ultrasound can assess lesion size and the smaller the nodule, the less likely that it is malignant. Therefore, we suggest a stepwise approach to small testicular masses, including tumorectomy, frozen section examination and radical orchiectomy or testis sparing surgery according to frozen section examination results.

Long-Term Surgical, Functional, and Patient Reported Outcomes of a Modified Corporoplasty: A Tertiary Referral Center Experience.

BACKGROUND: Nesbit corporoplasty was proposed to address penile curvature (PC), both congenital (CPC) and acquired (APC). AIM: To evaluate surgical, functional, and patient reported outcomes (PROs) of a modified corporoplasty. METHODS: From May 2005 to January 2017, a consecutive series of patients underwent a modified corporoplasty. Data were retrospectively extrapolated. Intra and postoperative complications and hospital stay were recorded as surgical outcomes. 2 validated international questionnaires were administered preoperatively and at 12 months after surgery: International Index of Erectile Function and Sexual Encounter Profile (items 2-3). An "ad hoc" questionnaire was utilized to assess PROs. OUTCOMES: Postoperative surgical and functional outcomes and PROs were the primary outcomes assessed in this study. RESULTS: 87 out of 145 patients had complete data available and were included in the study. CPC was noted in 61 patients whilst APC, secondary to Peyronie's disease, was present in 26 patients. Median preoperative PC was 60° (interquartile range [IQR] 45-70). Functional and PROs were evaluated 12 months after surgery for all enrolled patients. Considering surgical outcomes, the median follow-up time was 110 months (IQR 27-132.5). Median operative time was 130 minutes for CPC (IQR 115-150) and 120 minutes for APC (IQR 95-140). Median hospital stay was 2 days for both groups (IQR 1-2). After the median follow-up time of 110 months (IQR 27-132.5), a recurrent curvature was observed in 9.2% of cases. Minor residual curvature (<20°) was detected in 13.8%. International Index of Erectile Function and Sexual Encounter Profile 2-3 scores improved in both groups. Long-term de novo postoperative erectile dysfunction was observed in 3.2% of CPC cases and in 38.5% in APC (P = .001). A multivariate analysis revealed that etiology (APC), patient age (>35 years), and postoperative complications represented independent risk factors for the development of postoperative erectile dysfunction. Postoperative complications, in terms of bleeding, infection, or poor esthetic wound healing, occurred in 12.6% of patients. No Clavien-Dindo grade III-IV intraoperative complications were reported. Postoperative hematoma was more frequent in CPC when compared to APC (P = .003). In relation to PROs, 26.4% of patients responded as being dissatisfied with postoperative penile length, with a higher incidence in the APC group (P = .001). Overall, a significant improvement in everyday and sexual life quality was observed in both categories. CLINICAL IMPLICATIONS: The modified corporoplasty described showed better residual curvature rates, whilst maintaining similar PROs even if APC patients reported less favorable outcomes when compared to CPC. STRENGTHS & LIMITATIONS: The primary limitations of this study are its retrospective nature, no objective evaluation of postoperative curvature, and no penile length assessment. CONCLUSION: The aforementioned corporoplasty may represent an excellent option for PC correction, with low complication rate and high patient satisfaction. Falcone M, CerutiC, Preto M, et al. Long-Term Surgical, Functional, and Patient Reported Outcomes of a Modified Corporoplasty: A Tertiary Referral Center Experience. J Sex Med 2020;17:1779-1786.

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.

A Comparative Study Between 2 Different Grafts Used as Patches After Plaque Incision and Inflatable Penile Prosthesis Implantation for End-Stage Peyronie's Disease.

BACKGROUND: Although many grafts have been used for plaque incision with grafting (PIG) and penile prosthesis (PP) implantation, there is no evidence that favors 1 specific graft over another. AIM: To compare fibrin-coated collagen fleece (TachoSil; Baxter International, Deerfield, IL, USA) with porcine small intestinal submucosa (SIS; Cook Biotech, West Lafayette, IN, USA) as grafts. METHODS: From January 2007 to January 2015, 60 non-randomized consecutive patients affected by end-stage Peyronie disease underwent PIG and PP implantation (AMS 700CX; Boston Scientific, Marlborough, MA, USA). All patients underwent preoperative penile dynamic duplex ultrasound. All procedures were performed by the same surgeon. Patients were divided in 2 different groups according to the graft used to cover the albuginea defect. SIS was used for grafting in 34 patients (group A) and TachoSil was used in 26 patients (group B). OUTCOMES: Overall hospital stay, operative time, 5-point Likert hematoma scale, visual analog scale, incidence of postoperative complications, and PP mechanical failure were selected as outcome measures. Functional outcomes were assessed through validated questionnaires (International Index of Erectile Function, Erectile Dysfunction Inventory of Treatment Satisfaction, and Sexual Encounter Profile questions 2 and 3) preoperatively and 3, 6, and 12 months postoperatively. RESULTS: The patients' median age was 63 years. No statistically significant differences were detected between groups for age and type and degree of curvature (median = 65°). Average follow-up was 35 months. No major intraoperative complications were reported. The average operative time was 145 minutes for group A and 120 minutes for group B. No statistically significant differences between groups were detected for postoperative complications. Only 3 patients developed a major postoperative complication requiring a 2nd surgical intervention: 1 patient in group A for mechanic failure and 1 patient in group A and 1 in group B for inflatable PP infection. Multivariate statistical analysis showed no significant difference for all variables analyzed between the 2 groups, except for operative time, which was significantly shorter for group B. CLINICAL IMPLICATIONS: TachoSil could represent a valuable option for grafting, considering its advantages in operative time and cost compared with SIS. STRENGTHS AND LIMITATIONS: Long-term follow-up represents a strength factor. Main limitations are the non-randomized nature of the study and the small number of patients. CONCLUSIONS: TachoSil seems to represent an effective solution for grafting after PIG and PP implantation. However, additional studies are warranted to confirm our results. Falcone M, Preto M, Ceruti C, et al. A Comparative Study Between 2 Different Grafts Used as Patches After Plaque Incision and Inflatable Penile Prosthesis Implantation for End-Stage Peyronie's Disease. J Sex Med 2018;15:848-852.

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 prospective multicentric international study on the surgical outcomes and patients' satisfaction rates of the 'sliding' technique for end-stage Peyronie's disease with severe shortening of the penis and erectile dysfunction.

OBJECTIVES: To report the results from a prospective multicentric study of patients with Peyronie's disease (PD) treated with the 'sliding' technique (ST). PATIENTS AND METHODS: From June 2010 to January 2014, 28 consecutive patients affected by stable PD with severe penile shortening and end-stage erectile dysfunction (ED) were enrolled in three European PD tertiary referral centres. The validated International Index of Erectile Function (IIEF) questionnaire, the Sexual Encounter Profile (SEP) Questions 2 and 3, and the Peyronie's disease questionnaire (PDQ) were completed preoperatively by all patients. At the follow-up visits (at 3, 6 and 12 months), the IIEF, the SEP Questions 2 and 3, the PDQ, and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were completed. The outcome analysis was focused on penile length restoration, and intra- and postoperative complications classified according the Clavien-Dindo Classification. RESULTS: The mean (range) follow-up was 37 (9-60) months. A malleable penile prosthesis (PP) was implanted in seven patients, while an inflatable three-pieces PP was placed in the remainder. In the case of inflatable PP implantation, porcine small intestinal submucosa and acellular porcine dermal matrix were used to cover the tunical defects. While in patients undergoing malleable PP implantation, collagen-fibrin sponge was used. The mean operative time was 145 min in the inflatable PP group and 115 min in the malleable PP group. There were no intraoperative complications. Postoperative complications included profuse bleeding requiring a blood transfusion in one patient (3.5%) on anticoagulation therapy for a mechanical heart valve (Grade II) and PP infection requiring the removal of the device (7%) (Grade III). There were no late recurrences of the shaft deformation. The postoperative functional data showed a progressive improvement in the score of all questionnaires, peaking at 12 months postoperatively. The mean (range) penile lengthening was 3.2 (2.5-4) cm and no patient reported recurrence of the curvature. CONCLUSIONS: The present series suggests that, in the hands of experienced high-volume surgeons, penile length restoration with the use of the ST represents an effective option for end-stage PD associated with ED and severe shortening of the shaft. Larger series and longer follow-up will be required to fully establish the efficacy of this procedure.

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.

Global Practice Patterns and Variations in the Medical and Surgical Management of Non-Obstructive Azoospermia: Results of a World-Wide Survey, Guidelines and Expert Recommendations.

PURPOSE: Non-obstructive azoospermia (NOA) is a common, but complex problem, with multiple therapeutic options and a lack of clear guidelines. Hence, there is considerable controversy and marked variation in the management of NOA. This survey evaluates contemporary global practices related to medical and surgical management for patients with NOA. MATERIALS AND METHODS: A 56-question online survey covering various aspects of the evaluation and management of NOA was sent to specialists around the globe. This paper analyzes the results of the second half of the survey dealing with the management of NOA. Results have been compared to current guidelines, and expert recommendations have been provided using a Delphi process. RESULTS: Participants from 49 countries submitted 336 valid responses. Hormonal therapy for 3 to 6 months was suggested before surgical sperm retrieval (SSR) by 29.6% and 23.6% of participants for normogonadotropic hypogonadism and hypergonadotropic hypogonadism respectively. The SSR rate was reported as 50.0% by 26.0% to 50.0% of participants. Interestingly, 46.0% reported successful SSR in <10% of men with Klinefelter syndrome and 41.3% routinely recommended preimplantation genetic testing. Varicocele repair prior to SSR is recommended by 57.7%. Half of the respondents (57.4%) reported using ultrasound to identify the most vascularized areas in the testis for SSR. One-third proceed directly to microdissection testicular sperm extraction (mTESE) in every case of NOA while others use a staged approach. After a failed conventional TESE, 23.8% wait for 3 months, while 33.1% wait for 6 months before proceeding to mTESE. The cut-off of follicle-stimulating hormone for positive SSR was reported to be 12-19 IU/mL by 22.5% of participants and 20-40 IU/mL by 27.8%, while 31.8% reported no upper limit. CONCLUSIONS: This is the largest survey to date on the real-world medical and surgical management of NOA by reproductive experts. It demonstrates a diverse practice pattern and highlights the need for evidence-based international consensus guidelines.

Global Practice Patterns in the Evaluation of Non-Obstructive Azoospermia: Results of a World-Wide Survey and Expert Recommendations.

PURPOSE: Non-obstructive azoospermia (NOA) represents the persistent absence of sperm in ejaculate without obstruction, stemming from diverse disease processes. This survey explores global practices in NOA diagnosis, comparing them with guidelines and offering expert recommendations. MATERIALS AND METHODS: A 56-item questionnaire survey on NOA diagnosis and management was conducted globally from July to September 2022. This paper focuses on part 1, evaluating NOA diagnosis. Data from 367 participants across 49 countries were analyzed descriptively, with a Delphi process used for expert recommendations. RESULTS: Of 336 eligible responses, most participants were experienced attending physicians (70.93%). To diagnose azoospermia definitively, 81.7% requested two semen samples. Commonly ordered hormone tests included serum follicle-stimulating hormone (FSH) (97.0%), total testosterone (92.9%), and luteinizing hormone (86.9%). Genetic testing was requested by 66.6%, with karyotype analysis (86.2%) and Y chromosome microdeletions (88.3%) prevalent. Diagnostic testicular biopsy, distinguishing obstructive azoospermia (OA) from NOA, was not performed by 45.1%, while 34.6% did it selectively. Differentiation relied on physical examination (76.1%), serum hormone profiles (69.6%), and semen tests (68.1%). Expectations of finding sperm surgically were higher in men with normal FSH, larger testes, and a history of sperm in ejaculate. CONCLUSIONS: This expert survey, encompassing 367 participants from 49 countries, unveils congruence with recommended guidelines in NOA diagnosis. However, noteworthy disparities in practices suggest a need for evidence-based, international consensus guidelines to standardize NOA evaluation, addressing existing gaps in professional recommendations.

Phosphodiesterase type 5 inhibitor treatment for erectile dysfunction in patients with end-stage renal disease receiving dialysis or after renal transplantation.

INTRODUCTION: The phosphodiesterase type 5 (PDE5) inhibitors are generally well tolerated and effective for treating erectile dysfunction (ED), including in patients with significant comorbidity. Because of this benign safety profile, investigators have used PDE5 inhibitors to treat patients with ED and severe renal disease or those who have received renal transplants. AIM: To assess safety and efficacy of PDE5 inhibitors in patients receiving dialysis or renal transplants. MAIN OUTCOME MEASURES: Erectile function as assessed by the International Index of Erectile Function (IIEF) and Global Assessment Questions; adverse events (AEs). METHODS: We reviewed published studies of PDE5 inhibitors in patients receiving dialysis or renal transplants. RESULTS: In double-blind, placebo-controlled studies in patients receiving dialysis or renal transplants, sildenafil significantly improved erectile function as assessed by the IIEF, and 75-85% of patients reported improved erectile function on Global Assessment Questions; efficacy was more variable in less well-controlled studies. In >260 patients undergoing dialysis who received sildenafil in clinical studies, there were only six reported discontinuations because of AEs (headache [N=3], headache and nausea [N=1], gastrointestinal [N=1], and symptomatic blood pressure decrease [N=1]). In approximately 400 patients with renal transplants who received sildenafil, only three patients discontinued because of AEs. Vardenafil improved IIEF scores of up to 82% of renal transplant recipients in randomized, controlled studies (N=59, total), with no reported discontinuations because of AEs. Limited data also suggest benefit with tadalafil. CONCLUSIONS: ED is common in patients undergoing renal dialysis or postrenal transplant and substantially affects patient quality of life. Sildenafil and vardenafil appear to be efficacious and well tolerated in patients receiving renal dialysis or transplant.

The outcomes of surgical management options for adult acquired buried penis.

Functional and surgical outcomes after surgical correction of adult acquired buried penis (AABP) are limited in the current literature. We retrospectively recruited patients underwent surgical treatment of AABP in a single institution from 2017 to 2021. Surgical repair was classified according to surgical complexity following Pariser-Santucci's classification. The primary endpoint of the study was the recurrence-free rate survival. The secondary endpoints were surgical, functional and patients' reported outcomes. Overall 28 patients were included in the study. Median follow-up was 27.5 (18.5-34.5). The most common complaints at presentation were sexual (53.6%) and voiding (39.3%) dysfunction. Surgical management steps ranged from circumcision to more complex procedures, such as suprapubic fat pad excision, abdominoplasty and/or penile shaft skin grafting. Overall postoperative complications were recorded in 32.1%. High-grade complications (Clavien≥3) occurred in 7.1%. One-year recurrence-free survival was 88.7%. Postoperatively IPSS and IIEF-15 questionnaires showed a significant improvement in urinary 8 (0-12) vs 2 (0-3), p = 0.03 and sexual function 37 (23-68) vs 68 (45-72), p = 0.001 respectively. Overall, patients reported functional improvement and 93.8% experienced a positive impact of QoL. AABP surgical repair, despite the high incidence of complications, seems to allow satisfactory outcomes and a significant improvement in patients' QoL.

Bioengineered dermal matrix (Integra®) reduces donor site morbidity in total phallic construction with radial artery forearm free-flap.

Total phallic construction with radial artery forearm free-flap (RAFFF) is widely regarded as the gold standard approach for phalloplasty. However, donor-site morbidity remains a significant concern, which is typically managed by using a full-thickness skin graft (FTSG) on the forearm. Split thickness skin grafts (STSG) have been proposed as an alternative, along with the use of an acellular dermal matrix substitute. A retrospective comparative analysis was performed to assess the differences in operative, functional and cosmetic outcomes between FTSG (Group A) and the combination of acellular dermal matrix with STSG (Group B). A retrospective cohort study was conducted on all patients who underwent total phallic construction with RAFFF, between 2016 and 2021. Post-operative surgical and functional outcomes were evaluated using validated tools. A total of 34 patients were included in the study, with 18 patients (52.9%) in Group A and 16 patients (47.1%) in Group B. Group B demonstrated a significant advantage in terms of healing time (24 days vs. 30 days, p = 0.003) and complete graft take (93.8% vs. 27.8%, p = 0.001). Group B also had significantly shorter operative times (310 min vs. 447 min, p = 0.001) and a reduced median hospital stay (8 days vs. 10 days, p = 0.001). Satisfaction with cosmesis was significantly higher in Group B (93.8% vs. 66.7%, p = 0.048).

The outcomes of penile prosthesis in neurologic patients: a multicentric retrospective series.

Introduction: Neurological disease is a known entity for causing erectile dysfunction (ED). Pharmacological therapies are not always effective these patients - penile prosthesis implant (PPI) is an established surgical treatment option. For a variety of reasons, neurological patients may experience differing outcomes of PPI compared to those whose ED arises from other causes. We investigated outcomes of PPI in neurological patients using the Italian multi-institutional national registry of penile prostheses [Italian Nationwide Systematic Inventarization of Surgical Treatment for ED (INSIST-ED)]. Methods: Patients undergoing PPI were investigated via the INSIST-ED registry, from 2014 to 2021. Data were prospectively recorded by 45 surgeons on a dedicated website (www.registro.andrologiaitaliana.it) and reviewed by a data manager. We subselected patients with neurological disease undergoing PPI for ED, and these patients were reviewed at 3, 6, and 12 months, and annually thereafter. Postoperative complications and functional outcomes were evaluated through validated questionnaires [International Index of Erectile Function-5 (IIEF-5), Sexual Encounter Profile 2-3, and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)]. A nonvalidated questionnaire was administered to assess patient satisfaction. Results: A total of 33 patients were included with a median age of 49 [interquartile range (IQR) 41-55]. Median follow-up was 83 months (IQR 67-99.5). A penoscrotal approach for PPI was performed in most cases (90.9%), while infrapubic was used in three cases (9.1%). Inflatable and malleable devices were implanted in 30 (90.9%) and 3 cases (9.1%), respectively. Intraoperative complications occurred in one case (3%). Early postoperative complications (<90 days) were observed in three cases (9.1%): two wound dehiscence (Clavien-Dindo G1 and G3a respectively) and one device infection requiring prosthesis explant (Clavien-Dindo G3a). Mechanical failures of inflatable devices were not observed during the follow-up period. Median IIEF-5 before surgery was 8 (IQR 7-9). At the latest follow-up, IIEF-5 was 22 (IQR 19-23.5), and median EDITS was 79 (IQR 64-88). A total of 28 patients (84.8%) self-reported to be fully satisfied with the PPI. Conclusion: Although PPI in the neurological population has been historically considered to be at increased risk, in our study, PPI complications and infections rates in this cohort did not differ from general population.

Risk of unfavorable outcomes after penile prosthesis implantation - results from a national registry (INSIST-ED).

Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien-Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56-67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie's disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65-76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.

A new, innovative, lengthening surgical procedure for Peyronie's disease by penile prosthesis implantation with double dorsal-ventral patch graft: the "sliding technique".

INTRODUCTION: Peyronie's disease is the result of the formation of fibrous plaques in the tunica albuginea of the penis; typical presentations of the disease are represented by pain during erection, erectile dysfunction, and penile deformities, such as curvature, narrowing, and penile shortening. The most complex treatment is related to penile shortening. AIM: To find a safe procedure in penile shortening due to Peyronie's disease providing a satisfactory lengthening, allowing an early stabilization of the penis, and preventing axial tension on the neurovascular bundles during dilation. METHODS: We describe a new lengthening surgical procedure based on a ventro-dorsal incision of the tunica albuginea, penile prosthesis implantation, and double dorsal-ventral patch grafting with porcine small intestinal submucosa. Three patients, affected by Peyronie's disease with penile shortening and erectile dysfunction, underwent this procedure with approval of our local ethical committee. We evaluated the penis lengthening, intraoperative and postoperative complications, patient's preoperative and postoperative sexual life satisfaction (International Index of Erectile Function [IIEF] questionnaire). RESULTS: The average operative time was 2 hours and 50 minutes. No major intraoperative nor postoperative complications occurred. No significant bleedings were recorded. Patients were discharged after 48-72 hours. The average increase in length obtained was 3.2 cm. All patients resumed sexual intercourses with satisfaction; no significant loss of sensitivity or any sign of vascular distress of the glans was recorded. The follow-up is 13 months. The average IIEF score is 60. CONCLUSIONS: The lengthening of the penis by a double dorsal-ventral patch graft is an innovative procedure that is based on current techniques of plaque incision and grafting, and that can easily resolve severe shortening of the penis due to Peyronie's disease. In the cases presented, this procedure resulted easily, effectively, and safely. Nevertheless, the technique proposed in this article shall be validated through prospective studies with larger samples.