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Background Intracavernosal injections (ICI) are a well-established treatment option for men with erectile dysfunction (ED); however, the anticipation of pain with injection remains a significant barrier to the use of ICI. Aim To evaluate the patient-anticipated degree of pain versus the experienced degree of pain pre- and post-ICI in men undergoing their first injection with an erectile agent. Methods We studied 51 patients who underwent their first ICI in our men’s health clinic. Anticipated needle-associated pain was judged with a pre-injection score, and pain experienced during the injection was judged with a post-injection score. All patients graded their pre- and post-ICI pain using a standard 10-point scale (0–10). Outcomes Pre- and post-ICI pain was defined with the visual analogue scale (0–10) in men undergoing their first penile injection. Results Medians and interquartile ranges (IQRs) of the patients’ age [65 years (54.5–68.0)], pre-injection pain [5 (4–7)], and post-injection pain [1 (1–2)] were recorded. Most men in the study had erectile dysfunction (68.6%) and/or Peyronie’s Disease (64.7%). The average pre-injection prediction pain score was 5.45 ± 2.15; the average post-injection perceived pain score was 1.20 ± 0.73. Thus, there was an average discrepancy of over 4 points in predicted pain vs perceived pain. A paired t-test was performed which showed a statistically significant difference between pre- and post-injection scores (P < .05). A Wilcoxson Signed Rank Test showed statistical significance in the difference between pre- and post-injection pain scores (P < .05). Clinical Implications ICI is a safe, effective treatment for patients with ED and is associated with significantly less pain than is anticipated by patients. Strengths & Limitations This is the first report to describe the discrepancy between pre-ICI anticipated pain and post-ICI experienced pain. Limitations include an overall small sample size. Conclusion Patients experience significantly less pain with ICI than they anticipate having. This represents an important factor to consider when counseling patients about available ED treatments.

Background The use of plaque incision and graft techniques (PIG) for the treatment of severe Peyronie’s disease (PD), may lead to erectile dysfunction (ED); graft size is 1 of the contributing factors for post-PIG ED. Recently the iGrafter software APP was introduced using a mathematical algorithm to distribute the incisions along the penile length resulting in a smaller grafting area. Aim Compare 2 PIG techniques, the Double-Y(DY) and iGrafter, in 3 main aspects: (i) Total grafting area; (ii) The variation in calculating the grafting to be used; (iii) time to perform the PIG. Methods Six urologists with expertise in sexual medicine performed both techniques twice using four 3-D validated training models for PD with a standard 60° uniplanar dorsal curvature. Outcomes The graft areas and operative partial and total time for each step of the operation were recorded for each procedure. Unpaired t-test and the coefficient of variation for graft area across surgeons was calculated comparing both techniques. Results For all surgeons, the use of iGrafter resulted in 2 grafts, for the DY technique in 1 graft. Overall, TT for the iGrafter was significantly longer than for DY technique (49.4 ± 11 vs 40.7 ± 5.7 minute; P = .02), The iGrafter grafting area was significantly smaller (11.6 ± 1.2 vs 23.3 ± 5.4 cm2; P: .01), representing a 50.2% area reduction when compared to the DY. The variation of graft area, using the iGrafter also yielded a more consistent graft across all surgeons (CV = 10.56% vs 23.28%). Clinical Significance The iGrafter, when compared to DY technique, reduced the graft area by 50%, which potentially means less erectile dysfunction. Strengths and Limitations Our study eliminates anatomical variations found in a real clinical case making it possible to compare surgical techniques with the same penile anatomy. However, the 3D-printed model cannot replicate the living human tissue property preventing a simulation close to actual surgery. Conclusion The use of the iGrafter software for PIG surgery has shown to be a promising technique for severe PD management resulting in smaller graft size (about 50% smaller when compared to the DY), although it might be more time-consuming.

Background Despite an increasing number of publications on Peyronie’s disease (PD), evidence-based clinical decision-making remains challenging due to the small number of well-designed clinical trials. Aim To perform a critical analysis of reporting quality in PD systematic reviews (SR) and meta-analyses (MA). Methods Study protocol registration was performed on the Open Science Framework platform. In January 2021, a systematic electronic search of the Medline/PubMed, Embase, Ovid, Scopus, Joanne Briggs Institute, and Cochrane databases was performed. Search terms included “Peyronie’s disease” and “systematic review OR meta-analysis OR meta-analysis.” Eligibility criteria were English-language, relevance to PD and specification of “systematic review” or “meta-analysis” in the title or abstract. Oxford Center for Evidence-Based Medicine levels of evidence were used to classify original studies reviewed within each publication. Risk of bias was assessed using the ROBIS tool. Data were tabulated and reported as means with standard deviation, median with interquartile range and t-testing as appropriate. Strength of association between variables was calculated using Pearson correlation coefficient. Statistical analyses were performed on RStudio (version 1.4.1106). Outcomes Outcomes included review type, level of evidence, authorship, journal, publication date, “A MeaSurement Tool to Assess systematic Reviews” (AMSTAR-2) score and “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) score. Results From 1974 to 2021, 340 articles were identified. After review, 17 full length articles were included. Thirteen were SR, 2 MA and 2 was combined. Significant heterogeneity was seen in evidence level of included studies. There was median 54% adherence to AMSTAR-2 criteria and 74% adherence to PRISMA criteria. Overall AMSTAR-2 confidence rating was Critically Low in 11 of 17 studies. Correlation analysis revealed very high positive association between AMSTAR 2 and PRISMA adherence (+0.95). ROBIS revealed “High” concern regarding methods used to collect data and appraise 12/17 studies (71%), and “High” concern regarding synthesis and findings in 8 of 17 studies (47%). Clinical Implications Many SR include markedly heterogenous levels of evidence and fail to meet accepted methodological criteria for reporting. Strengths and Limitations Main strengths include extensive literature review and analysis of standardized study reporting. One limitation is that aggregate scoring of AMSTAR-2 and PRISMA is not intended as primary method of quality assessment; however effect was minimized by reporting critical domains, overall quality assessments and specifics on globally poorly reported domains. Conclusion More high quality randomized controlled PD trials are necessary; SR and MA should focus on these studies alone.

Background Congenital penile curvature (CPC) is corrected surgically by various corporoplasty or tunica albuginea plication techniques, but the optimal surgical approach is not well-defined. Aim To provide a comprehensive evaluation of the published literature pertaining to outcomes with penile plication and corporoplasty techniques for surgical management of CPC. To determine if plication or corporoplasty offers superior outcomes in surgical correction of CPC. Methods A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Checklist. The following databases were queried from inception to March 18, 2020 to search for studies describing surgical treatment of CPC: Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Outcomes Objective and subjective postoperative outcomes including penile straightening, shortening, penile sensory changes, and reoperation rates for both corporoplasty and tunica albuginea plication were summarized. Results Fifty-five articles comprising 2,956 patients with CPC who underwent a plication procedure (n = 1,375) or corporoplasty (n = 1,580) were included. The definition of “treatment success” varied widely and most often involved subjective patient reporting (22 studies; 40%) or objective assessment (15 studies; 27%). We considered curvature correction to be satisfactory if there was self-reported patient satisfaction or residual curvature after correction of Clinical Implications While both plication and corporoplasty appear to be safe and effective options in the treatment of CPC, definitive conclusions cannot be drawn with respect to treatment superiority due to low-quality study design, methodology flaws, and significant heterogeneity in reporting. Strength & Limitations This report represents the most comprehensive review of CPC surgical management. However, there is a significant lack of standardization in the reporting of treatment outcomes for CPC, thereby limiting the reliability of the published data summarization encompassed by our review. Conclusion Both plication and corporoplasty demonstrate high success rates and relatively low complication rates in the treatment of CPC, albeit with low-level evidence available in most research publications. Robust comparison of the surgical techniques used to correct CPC is limited by significant variation in reporting methods used in the literature.

Background Peyronie’s disease (PD) is associated with penile pain, deviation, and sexual dysfunction. Up till now, there is no conservative standard treatment for PD. However, the role of Extracorporeal Shock Wave Therapy (ESWT) is gaining increasing interest. Aim To evaluate the effect of ESWT on penile deviation, plaque size, erectile function, pain scale, and the rate of complications in PD patients. Methods PubMed database was searched for articles published from January 2000 to November 2020, using related keywords and including randomized controlled trials (RCTs) only. Meta-analysis and forest plots were carried out using RevMan, and outcomes were reviewed by 2 authors independently. PRISMA guidelines were used in this article to achieve the quantitative and qualitative synthesis of data. Outcomes Changes in penile deviation, plaque size, erectile function, pain scale, and the rate of ESWT related complications. RESULTS The search yielded 73 articles. Three RCTs, including 117 patients in the ESWT group and 121 patients in the placebo group, were reviewed. ESWT is associated with reduction in plaque size (OR = 2.59, 95% CI (1.15–5.85), P= .02). No significant difference in reduction of penile deviation angle or rate of bruises were detected in post ESWT group when compared to placebo. No evidence was found to show an effect of ESWT on erectile function or pain scale. Clinical Implications Based on the available RCTs, ESWT fails to improve penile curvature or pain in men with PD. Although ESWT may reduce plaque size, this remains of questionable clinical significance. Strengths & Limitations RCTs used different metrics to report the same outcome. Missed data were imputed to match the requirements of meta-analysis. However, there is still much data that cannot be estimated. CONCLUSION The current data suggest that ESWT fails to improve penile curvature or pain in men with PD. Although ESWT may reduce plaque size, this remains of questionable clinical significance, and further studies are required to confirm findings.

Background Intralesional collagenase such as Xiaflex (ILX) has become a standard treatment for Peyronie’s disease (PD). Many robust studies have demonstrated its clear efficacy in the treatment algorithm. Aim To examine predictors of the patient decision to pursue ILX in PD patients. Methods The study included PD patients (i) with stable disease (ii) who had doppler duplex ultrasonography (DUS) at least 6 months prior to analysis date and (iii) did not choose an operation. All patients received a standard discussion regarding treatment options, specifically, observation, ILX and penile reconstructive surgery (plication, plaque incision and grafting, implant surgery). Patients who opted to use ILX were compared to those who opted against it. Comorbidity, demographic and PD characteristics were recorded at the initial PD visit. All patients completed three validated questionnaires including the PD questionnaire (PDQ), Self-Esteem and Relationship (SEAR) questionnaire and a depression questionnaire (CES-D). Logistic regression was used to determine predictors of ILX use. Outcomes Predictors of ILX utilization. RESULTS Four hundred and fifty stable PD men had DUS completed 6 months before to allow sufficient time for treatment decision. Of these, 111 (24.7%) patients had ILX treatment and 339 (75.3%) did not. Mean age, relationship status and pain occurrence were similar between groups, but ILX patients had less bother defined as PDQ ≥ 9 (46.8% vs 53.7%, P = .02). ILX patients had more complex curves (79.3% vs 47.8%, P < .01) and more severe instability (32.4% vs 15.3%, P = .01). ILX patients also had higher PDQ domain scores (Psychological 11.5 ± 6.4 vs 7.5 ± 6.2, P < .01; Pain 6.2 ± 6.0 vs 4.3 ± 5.6, P = .02; and Bother 9.8 ± 4.7 vs 6.6 ± 4.8, P < .01). On univariable statistics, significant bother (OR 2.41, 95% CI 1.36–4.28, P Clinical Implications Educates providers as to which patients are more likely to choose ILX. Strengths & Limitations Our study has a large sample size and all patients received the same standardized treatment discussion. Our study is limited by the absence of insurance data on all patients, and its retrospective single center design. CONCLUSION ILX was chosen by the minority of stable PD patients. While moderate to severe instability and significant bother is predictive of ILX use, other demographic factors including relationship status, sexual orientation or pain were not.

Background/aim We aimed to evaluate the effectiveness and safety of penile plaque incision and buccal mucosa grafting in patients with stable-phase Peyronie’s disease (PD). Methods This was a prospective evaluation of patients with stable-phase PD who were treated by plaque incision and buccal mucosa grafting. Preoperative evaluation included International Index of Erectile Function Questionnaire (IIEF-5), measurement of erect penile length, and penile Doppler ultrasound during prostaglandin-induced erection. At 3- and 24-month follow-up visits, penile length and residual curvature were measured along with penile Doppler ultrasound and IIEF5 questionnaires. Patient and sexual partner satisfaction were also assessed at 24-month-visit. RESULTS The study was completed with 20 patients (mean age 46.5 ± 9.9 years). Dorsal curvature was the most frequent site of curvature (45%). The median curvature at preoperative evaluation was 45°(range 40-90°). The postoperative median curvatures were 5°(5-10, IQR) and 7°(5-10, IQR) at 3- and 24-month postoperatively, respectively. Success rate was 95% at 3-month and 90% at 24-month. There was no significant penile shortening. The mean IIEF-5 score was 17.5 ± 2.2 at preoperative evaluation. The median IIEF-5 scores were calculated as 20.1 ± 2.2 and 21.3 ± 2.2 at 3-month and 24-month visits, respectively (p CONCLUSION Corporoplasty with buccal mucosa graft led to excellent structural and functional results and patient satisfaction.

Background It is currently unclear if men with Peyronie’s Disease (PD) who achieve minimal benefits with the first 2 series of Collagenase Clostridium Histolyticum (CCH) injections should continue with additional injections. Aim To analyze curvature improvements from the final two series of CCH injections based on amount of improvement during the first 2 series. Methods A prospective registry was analyzed of all men undergoing CCH injections for PD at a single institution. Men were included if they had completed a full 4 series (8 injections) of CCH and had baseline, interval (after 2 series), and/or final (after 4 series) curvature assessments available. Men were stratified into cohorts using baseline-to-interval assessments of ≤10° (or ≤20%) and >10° (or >20%), and improvements were compared using interval-to-final assessments. Outcomes The primary outcome was interval-to-final curvature improvements stratified by ≤10°/>10° or ≤20%/>20% improvements achieved during the baseline-to-interval period. Secondary outcomes included analyses of demographic and pathophysiologic variables to determine associations with significant improvements during the final 2 CCH series. RESULTS A total of 296 PD men were identified as receiving at least one CCH injection, of whom 175 had baseline-to-interval, 84 interval-to-final, and 115 with baseline-to-final measurements. Mean age was 56.6, PD duration 28.6 months, baseline curvature 63.4°, hourglass deformity 36.2%, and calcification 20%. Mean overall curve improvement was −21.5° (33.1%). Among men who experienced ≤20% improvements after 2 series, the mean subsequent curvature change was -24.6% during the final two series (vs +4.3% of those with >20% initial improvement, P< .001), and they were 2.7x more likely to experience >20% subsequent curve improvements. Thirty-one percent of those who achieved >10° during the first 2 series experienced benefits during the final 2 series compared to 70% of men who had ≤10° improvement initially. No demographic or pathophysiological variables predicted likelihood for improvements during the final 2 series of injections. Clinical Implications Men who fail to achieve significant benefits with 2 series of CCH injections may benefit from completing the final 2 series. Strengths and Limitations Strengths including a relatively large, prospective series. Limitations include a single center, nonrandomization, nonblinded assessments, and restriction to men who completed eight injections. CONCLUSIONS In the current series, approximately 2/3 of men who fail to achieve >10° or 20% curve improvements with an initial 2 series of CCH injections achieved >10° or 20% improvements with the subsequent 2 series.

Introduction Penile curvature is the most common abnormality that is observed by men with Peyronie's disease (PD). Collagenase Clostridium histolyticum (CCH) has become a standard treatment for PD patients. Aim To identify predictor factors associated with improvements of penile curvature outcomes in men with PD treated with CCH. Methods We retrospectively collected the data of patients with PD treated with CCH up to 8 injections divided into 4 cycles between January 2014 and July 2020. Per protocol, penile curvature was assessed at baseline, and after the second and ford CCH cycle. If after cycle 2, curvature demonstrated no improvement, or penile curvature was significantly improved and the patient was happy, no further treatment was recommended. However, if penile curvature was significantly improved and the patient remained dissatisfied, 4 cycles were completed. Three categories of response were evaluated: improvement (≥10 degrees or ≥20%, either 1 happens), unchanged (±10 degrees or ±20%) or worsened (≥10 degrees or ≥20%, either 1 happens). Logistic regression analyses were performed to evaluate predictive factors associated with penile curvature improvements. Outcomes Degrees of the curvature changes between the baseline and after the cycles of CCH. Results A total of 114 patients underwent CCH treatment. Median age was 57 years. Median PD duration was 11 months. At baseline, mean curvature was 47 degrees, 65% had dorsal curvature, 53% mid-shaft location, and 15% calcification. After CCH treatment, the mean final curvature was 40 degrees. A total of 44% improved the curvature, 39% had no change while 17% worsened after CCH treatment. Of men who had penile curvature improvement with CCH treatment, the mean curvature decreasing in degrees and percentage were 22 degrees and 41%, respectively. Men with baseline curvature ≤ 30, 31–59, and ≥ 60 degrees, the percentage curvature improvement were 29%, 43%, and 60%, respectively. Baseline curvature was the only significant predictor of penile curvature improvement after CCH (OR 1.33, 95% CI = 1.1, 1.7). Clinical Implications We confirmed baseline penile curvature is the most important predictive factor, and this is the first report describing proportions of penile curvature improvement with CCH treatment. Strengths and Limitations This study has several strengths, including the use of validated instruments. Nonetheless, there are limitations: the retrospective nature of the study, a single institution; and modelling device was not controlled. Conclusion Penile curvature improvement was significantly more common in patients with greater baseline curvature, reaching up to 60% for patients with ≥ 60 degrees.

Background A xenograft consisting of equine collagen coated with human fibrinogen and thrombin (TachoSil; Baxter, CA) has recently been introduced in grafting procedures for Peyronie’s disease (PD). Aim To describe the results of a multicenter prospective registry on patients with PD undergoing plaque incision or and grafting (PIG) or plaque excision and grafting (PEG) with collagen fleece TachoSil, to evaluate the efficacy and safety of this procedure. Methods A prospective non-controlled multicenter study of patients with PD was performed between May 2016 and March 2018. Patients from 10 centers with stable PD for at least 3 months, difficulties in sexual intercourse, normal erectile function with or without pharmacological treatment, curvature >45°, and/or penile shortening and/or complex deformities were included. All patients underwent PIG/PEG with collagen fleece TachoSil. Outcomes The main outcome measure of this study were penile curvature correction (intraoperative), penile shortening (intraoperative), erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) and the Erection Hardness Score, subjective patient outcomes with non-validated questionnaires, and complications. Results A total of 52 patients were enrolled in the study. The mean (SD) preoperative penile curvature was 72.8° (17.0). PIG was the preferred technique (80.8%). Intraoperatively, complete curvature correction was achieved in 92.3%, and no significant penile shortening was recorded in 80.8% of subjects. Subjective penile shortening was reported in 83.3% of patients at 6 months. No objective measurement of penile curvature and length was recorded during follow-up. No statistically significant difference from the baseline was found in IIEF-5 and Erection Hardness Score at 3 or at 6 months, although 16.7% of men experienced a worsening of IIEF-5 scores and 14.3% required de novo phosphodiesterase type 5 inhibitor use. 6 months after surgery, 78.5% of men were satisfied with intervention. Swelling and ecchymosis/hematoma were the most common perioperative complications (40.4%). 2 cases (3.8%) of wound infection were recorded. At 6 months, 35.7% of patients reported mild penile hypesthesia. Clinical implications Our results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening. Strength & Limitations This is the first multicentre study on patients with PD undergoing grafting with TachoSil without concomitant placement of penile prosthesis. The main limitations are the short follow-up and the relatively small sample size. Conclusion Grafting with TachoSil after PIG/PEG in patients with PD is an effective and safe procedure. Among the main advantages of this technique, there are ease of use of the graft and reduced operative time.

Background Men with Peyronie's disease (PD) may experience penile narrowing. Little data on penile girth changes and their psychosocial impact exist. Aim To assess girth discrepancy in men with PD and its association with patient bother. Methods This was a retrospective observational study. All patients with PD at our institution who were seen in the sexual medicine clinic and who completed 3 validated instruments the PD questionnaire (PDQ), Self-Esteem and Relationship (SEAR) questionnaire, and a depression questionnaire, the Center for Epidemiologic Studies Depression Scale (CES-D), and a curvature assessment were included. Patient and PD characteristics are described. Associations of instability and bother to girth differences are assessed. 2 outcomes for girth differences are classified as (i) girth difference of ≥ 1 cm vs less and (ii) girth differences of ≥10% vs less. Unadjusted and adjusted effects of PD and patient characteristics are assessed on the outcome of high bother using logistic regression models. Outcomes The main outcomes of this study were penile girth changes, instability, and questionnaire scores. High bother was defined as a PDQ bother score of ≥9. Results A total of131 men had midshaft curvature and were the focus of the study. Their mean age was 59 ± 9 (range 31–78) years. PD duration was 16 ± 25 (range 1–180) months, with a mean degree of primary curvature of 37 ± 20o. Mean girth difference between base and point of maximum curvature was 0.78 ± 0.53 cm equating to a mean girth difference at point of maximum curvature of 6 ± 4%. Instability was present in 53% of men. There were 54 men with a girth difference of ≥ 1 cm and 23 men with a ≥10% change in girth. There was no difference in CES-D, SEAR, or PDQ domain scores or high bother in men with significant girth changes. Univariable analysis of predictors of high bother included the degree of curvature (odds ratio [OR]: 1.06; P Clinical Implications Penile girth changes have little impact on overall psychosocial well-being. The degree of penile curvature is the primary predictor of patient bother. Strengths and Limitations Strengths include a large patient population and use of validated questionnaires. Limitations include single-center, retrospective study and subjective instability grading. Conclusions Penile girth discrepancy in men with PD has limited psychosocial impact. Clinically significant bother was associated with the degree of primary curvature.

Background In recent years, the assessment of erectile dysfunction (ED) has experienced a paradigm shift from objective, quantitative methods to subjective, qualitative patient-reported outcomes. Facilitated by this shift is the ongoing debate on questionnaire selection and need for standardization, particularly among sexual medicine specialists. Aim To review current literature on assessment of erectile function via patient-reported outcomes and discuss the context, advantages, and limitations of currently available questionnaires. Methods A thorough literature search of erectile function questionnaires developed from 1990 through 2019 was carried out using 3 methods: a search of the MedLine databases; hand-search of peer-reviewed urologic, sexual medicine, and health policy journals; and expert review. The following keywords were used: [assessment of], [inventory], [questionnaire], or [validated measure]; in combination with: [sexual function] or [erectile function]. Measures were stratified into one of the following 3 groups: screening, outcome, or disease-specific. 3 screening measures (International Index of Erectile Function, the Male Sexual Health Questionnaire, and Brief Male Sexual Inventory); 5 outcome measures (Sexual Health Inventory for Men, Erection Hardness Score, Erectile Dysfunction Inventory for Treatment and Satisfaction, and Treatment Satisfaction Scale); and 3 categories of disease-specific measures (cancer, Peyronie's disease, and spinal cord injury) were included. Outcomes Strengths, limitations, and valid uses of each erectile function questionnaire. Results There currently exists a wide variety of screening, outcome, and disease-specific measures for ED diagnosis, assessment, and treatment. Rigor of psychometric validation varies greatly across studies. However, depending on purpose of use, all abovementioned questionnaires have merit for use in clinical practice, are nonredundant, and can complement and supplement one another. Clinical Implications Before choosing a specific measure for ED diagnosis, assessment, or treatment, there must be careful consideration of the questionnaire's psychometric properties, context of validation, and its possible limitations. Strengths & Limitations The patient reported outcome measures highlighted in this article complement and supplement one another, as each emphasizes a related yet distinct central theme. During selection for use in clinical practice and research studies, special attention needs to be paid to the context, strengths, and weaknesses of each measure. Conclusion When used conscientiously, patient-reported questionnaires can significantly optimize patient management.

Background A subset of patients with Peyronie's disease (PD) treated with collagenase clostridium histolyticum (CCH) experience persistent bother and some require surgery. Aim We characterize patients experiencing persistent bother after CCH treatment and identify associations and predictors of surgical intervention/outcomes. Methods We retrospectively identified patients with PD from October 2014 to October 2019 and identified those presenting with persistent bother after CCH treatment by other urologists. Intracavernosal injection and penile Doppler ultrasonography were performed, and subsequent interventions/outcomes were recorded. Baseline characteristics were compared with Student t-test and chi-square test. Predictors of surgical intervention and complications were assessed using multivariable logistic regression. Outcomes The primary outcome was surgery after CCH treatment. Secondary outcomes included worsened erectile function, sensory deficits, and penile length change. Results Of 573, 67 (11.7%) patients with PD had undergone prior CCH treatment with median 6 injections (range 2–24). Mean post-CCH PD Questionnaire bother score was 10.1 (SD: 3.1), and total International Index of Erectile Function-5 was 15.3 (SD: 8.7). Mean PD duration was 27.8 (SD: 35.7) months, with a mean composite curvature (MCC) of 69.0° (SD: 33.8) measured after injection. Of 67, 44 (65.7%) patients had MCC >60°. Of 67, 52 (77.6%) patients had indent, narrowing, or hourglass and 26 (38.8%) had hinge effect (buckling of the erect penis with axial pressure) on examination. Calcification was identified in 26 of 67 (38.8%) patients, with grade 3 calcifications comprising 6 of 23 (26.1%) patients. Of 67, 33 (49.3%) patients underwent surgery, with 20 (60.1%) undergoing partial plaque excision and grafting with/without tunica albuginea plication, 6 (18.2%) undergoing tunica albuginea plication alone, and 7 (21.2%) undergoing penile prosthesis with plaque incision and grafting. Surgical patients had greater mean curvature (82.6 vs 55.4, P = .001) and were more likely to have hinge (54.5% vs 20.6%, P = .005). On multivariable analysis, MCC ≥60° predicted patient’s decision for surgery (odds ratio: 2.99, P Clinical Implications Patients presenting with persistent bother after CCH treatment often have narrowing and calcifications (despite calcifications being a contraindication to CCH treatment), and those who have hinge or severe curvature are more likely to undergo surgery with low rates of complications. Strengths/Limitations This study's generalizability is limited by selection bias, but useful data are provided for patient counseling. Conclusion Patients with persistent bother after CCH treatment had high rates of indentation/narrowing, plaque calcifications, and MCC >60° at completion of CCH treatment. Surgical intervention is more common with hinge and is safe and feasible in these patients, with low rates of complications. These findings suggest possible negative prognostic factors for CCH treatment, which merit further investigation.

Introduction Although an infrequent cause of small penile size in adult men, acquired penile shortening represents a particular reconstructive challenge due to preexisting penile anatomic deformities. Aim With numerous techniques being performed, the purpose of our study is to assess available literature on length enhancement procedures used for acquired penile shortening deformities. Methods A systematic review was performed using the guidelines outlined in the Preferred Reporting Items for Systematic reviews and Meta-analyses. Medline/PubMed, Scopus, and Cochrane Databases were used to identify papers on augmentation Phalloplasty in non-transgender males with acquired penile shortening from 1990 to 2018. Main Outcome Measure Outcomes, complications, and patient-reported satisfaction were analyzed. Results 12 articles, involving 931 patients and 8 primary procedures, met our inclusion criteria. The majority of articles had level of evidence of 4 (83%) and Newcastle Ottawa Scale score of 6 (92%, moderate risk of bias). All studies reported mean penile length gain; however, inconsistent methodology was used when measuring penile dimensions. Mean length gain ranged from 0.6 to 6.4 cm. Overall, the mean complication rate for all techniques ranged from 0% to 50%. Post-operative satisfaction was reported in 10 (83%) studies, 7 of which used a validated scale. Patients were generally satisfied, with reported satisfaction rates ranging from 77% to 100%. Clinical Implications While numerous procedures have been described, the significant limitations in the available data preclude identifying a single superior procedure. Strengths & Limitations The significant heterogeneity in the reported literature is a limitation of this study and highlights the need for standardized reporting. However, this study is the first to analyze augmentation phalloplasty literature in the setting of acquired penile shortening. Conclusion Augmentation phalloplasty techniques for acquired penile shortening are evolving and are continuously being modified; best-practice guidelines are crucial to achieve safe and satisfactory outcomes in this population.

Objectives To present the surgical results and the functional outcomes after surgical correction of congenital penile curvature (CPC) by different plication techniques. Methods All consecutive patients operated for CPC from 2010 to 2019 in a university hospital of Lyon, France, were retrospectively identified and included for analyzing surgical results. They were proposed to answer a questionnaire (between January 2020 and May 2020) that included questions of the Peyronie's Disease Questionnaire (PDQ), the Erection Hardness Score (EHS), and the Internal Index of Erectile Function (IIEF5), along with non-validated specific questionnaires. Results A total of 31 patients were included, their mean (SD) age was 21.2 (4.9) years, their mean (SD) follow-up of 55.5 (33.7) months. The principal curvature was ventral for 25 (80.6%) patients. After the surgery, 28 (90.3%) patients had straight penis or a residual curvature less than 15°, and 2 (6.5%) required a second surgery. A total of 23 (74.2%) patients answered the post-operative questionnaire. The mean (SD) scores were 1.2/16 (1.8) for PDQ-Bothered Score, 1.5/24 (2.1) for PDQ Psychological and Physical, and 1.7/30 (2.7) for PDQ pain. The mean (SD) IIEF5 was 22.7/25 (4.6). All patients had an EHS of 4/4. There were 10 patients who never had sexual intercourse before the surgery and 4 who still had not when answering the questionnaire. All patients (23/23) were either “satisfied” or “very satisfied” with the outcomes of the operation, and 13 (56.5%) reported improvement of their sexual life after surgery. Conclusion This study confirmed the favorable outcomes of surgical plication for CPC with low morbidity. A concomitant sexological care may be useful for some patients.

Introduction Penile plication or partial excision with grafting has traditionally been the first-line treatment for stable Peyronie’s disease (PD). Numerous injection therapies (ITs) have been introduced over the last few decades. Intralesional collagenase clostridium histolyticum (CCH) was U.S. Food and Drug Administration approved in 2013 for patients with stable disease, curvature ≥30° and ≤90°, and intact erectile function. The impact of the advent of CCH on the surgical management of PD is unknown. Aim We studied the effect of IT on the surgical management of PD in a population-based analysis. Methods The Statewide Planning and Research Cooperative System database, which provides statewide level of all-payer data on patients in the outpatient, inpatient, ambulatory, and emergency department setting in New York State was reviewed. Patients undergoing a penile prosthesis for concurrent erectile dysfunction were excluded. Main Outcome Measure Descriptive statistics and multivariable logistic regression modeling were used to assess factors influencing choice of injection therapy vs surgical therapy (penile plication or partial excision with grafting). Results From 2003−2016, 547 patients with PD presented for management. Median age was 56 years and 57% were white. Over the study period, surgical management was used less often as the primary procedure with a concurrent increase in use of IT (P < .001). On multivariable modeling, patients more likely to receive IT as treatment for penile curvature were younger (odds ratio [OR]: 1.26; P = .002; CI: 1.09−1.46), of higher socioeconomic status (OR: 1.14; P = .037; CI: 1.01−1.29), presented in the post-CCH era (OR: 1.17; P = .018; CI: 1.03−1.33) and presented to a surgeon with a high volume practice (OR: 1.25; P = .007; CI: 1.07−1.48). Patients presenting in the post-CCH era were 17% significantly more likely to receive IT. Clinical Implications ITs like CCH are increasingly displacing surgical management as the primary treatment option of Peyronie’s disease. Strengths & Limitations The Statewide Planning and Research Cooperative System database is particularly useful for this analysis because it is an all-payer database that tracks patients longitudinally across various health care settings—outpatient and inpatient. Limitations: It only includes patients in New York State limiting generalizability. The retrospective nature of the analysis makes it subject to the biases inherent in such reports. Specific disease level characteristics (eg, degree of curvature, duration of disease, and associated deformities) were not available. Conclusion Since the introduction of CCH, there has been a markedly decreasing trend in the utilization of surgery as the primary modality in the management of PD-associated penile curvature.

Introduction Surgery remains the gold standard for the correction of penile deformities secondary to Peyronie’s disease (PD). Nevertheless, there is no published data on the surgical treatment of PD in older men. Aim Considering the aging national and international population, we sought to evaluate the pre-operative characteristics and surgical outcomes of men aged 65 or older who underwent surgical treatment for PD at our tertiary care institution. Methods We retrospectively reviewed the charts of all men 65 years or older who underwent surgery for PD from January 2010 to September 2017. We compared men who underwent penile prosthesis implantation with straightening maneuvers (PP+SMs), tunica albuginea plication (TAP), and plaque partial excision with grafting (PEG). Main Outcome Measure The main objective of this study was to find the baseline pre-operative patient characteristics and postoperative patient-reported outcomes. Results A total of 86 men with a median age of 68 years underwent surgery during the study period. 39 men underwent PP+SM (45%), 25 men a TAP (29%), and 22 men a PEG (26%). The mean curvature for all men was 59.9 ± 22.0° (range 0−105°). Those who underwent a PEG had a mean ± SD degree of curvature of 78.6 ± 16.6°, significantly higher than those who underwent PP+SM or TAP (49.1 ± 20.2° and 61.4 ± 17.4°, respectively; P < .001). Moreover, men who underwent a PEG had significantly more complex penile deformities (eg, narrowing with hinge effect) and better reported baseline erectile function compared with men who underwent PP+SM or TAP. Overall, 95% of all men reported having a functionally straight penis postoperatively with 94% engaging in penetrative intercourse at last follow-up. Overall, patient-reported satisfaction was 85% with a median follow-up of 43.5 months. Clinical Implications Our findings suggest that the surgical treatment of PD in older men is safe, effective, and associated with high patient satisfaction. Although this represents a surgical series susceptible to selection bias, it underscores the importance of patient selection and counseling in achieving good surgical outcomes. Strengths & Limitations Our study is the first to report on outcomes of surgical treatment of PD in an elderly patient population with relatively long-term follow-up. Our limitations include a small sample size, single operating surgeon, and the lack of a younger comparison group. Conclusion Despite an aging global population, surgery remains a viable and reliable option for the properly selected and counseled older men with PD.

Introduction Hydraulic penile prostheses have shown an overall good mechanical reliability up to 10 years after surgery; however, few data have been published on very long-term follow-up. Aim We looked at long-term (≥15 years) complications, including functional and quality of life (QoL) outcomes, after 3-piece inflatable penile prosthesis (IPP) implantation in patients with erectile dysfunction (ED). Methods Data regarding 149 patients submitting to IPP placement before 2001 were analyzed. All patients were implanted with AMS CX and Ultrex Plus 3-piece prostheses. Main Outcome Measure Patients were reassessed to evaluate rates of complications and functional outcomes. The validated questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) was used to assess patient QoL. Kaplan-Meier analysis estimated the probability of prosthesis survival (defined as working device/not-explanted). Results Median follow-up of 51 patients was 206 months (interquartile range [IQR], 145–257). The etiology of ED was vasculogenic (n = 20; 39%), Peyronie’s disease (n = 15; 29%), pelvic surgery (n = 4; 7.8%), organic other than vasculogenic (n = 3; 5.9%), or other (n = 9; 18%). Throughout the follow-up, 24 patients (49%) experienced complications: mechanical failure (n = 19; 79%), pain (n = 3; 12%), orgasmic dysfunctions (n = 1; 4.5%), or device infection (n = 1; 4.5%). The estimated IPP survival was 53% (95% CI, 36–67) at 20-year follow-up. Baseline characteristics (age, Charlson comorbidity index, body mass index, and erectile dysfunction etiology) were not significantly associated with the risk of IPP failure over time by Cox regression analysis. At 20-year follow-up, 41% (95% CI, 19–49) of the patients were still using the device. Among them, QoLSPP median domain scores were high: functional 22/25 (IQR, 20–23), relational 17/20 (IQR, 15–18), personal 14/15 (IQR, 12–15), and social 14/15 (IQR, 11–15). Clinical Implications The longevity of the device and long-term satisfaction rates should be comprehensively discussed during patient consultation for IPP surgery. Strengths & Limitations To our knowledge, this is the first study reporting long-term QoL outcomes using a dedicated questionnaire for penile prostheses. The low response rate for the telephone interviews, the retrospective design of the study, and the relatively small number of patients are the main limitations. Conclusion Long-term follow-up data after IPP placement showed that almost half of the devices still worked properly 20 years after the original penile implant, as 60% of patients were still using the device with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the expected life and outcomes of IPP implants.

Introduction Peyronie’s disease (PD) is a progressive and devastating penile disorder that often results in severe penile curvature with penile shrinking, making vaginal insertion difficult or even impossible. Until now, in contrast to other penile disorders such as erectile dysfunction, PD is characterized by a paucity of conservative treatment options. Aim To investigate the current status quo in the management of PD across European experts in sexual medicine. Methods Members of the European Society of Sexual Medicine and of various andrology and urology societies across Europe, with the majority (78%) being urologists, were contacted via e-mail and newsletters and asked to fill in an online questionnaire. The survey comprised 56 items developed by an expert consensus of the educational committee of the European Society of Sexual Medicine. In the end, 401 participants responded to the entire survey, with 277 reporting treating PD patients themselves and knowing this penile entity very well. Main Outcome Measures Main outcome measures include description of current strategies regarding diagnosis and treatment of PD as reported by specialists in this field. Results Of the physicians treating PD patients, 94% performed penile palpation, and 74% perform ultrasonography. 45% assessed the degree of penile curvature by means of intravenous drug testing, but only 17% measured it accurately with a goniometer. Penile length, flaccid or in erect state, was measured by only 39% or 25%, respectively. Only 45% assessed testosterone. Primary treatment options were oral (65%), counseling (57%), and topical/local therapy (30%). Among oral drug users, tadalafil 5 mg was the most commonly used (57%), followed by vitamin E (40%). Regarding intralesional therapy, collagenase clostridium histolyticum was the leading drug (34%), followed by calcium channel blockers (17%). Considering surgical procedures, the original Nesbit technique was the preferred procedure (33%). 36% of the specialists expressed their dissatisfaction with the currently available treatment options, and 64% reported the impression that their patients were mostly dissatisfied with the treatment outcomes. Clinical Implications Innovative and presumably multi-modal treatment protocols for PD are urgently needed. Strengths & Limitations The survey represents 1 of the largest studies on the management of PD. The results are representative for the standard management of PD mostly among European Urologists with specialization in sexual medicine and may therefore not be generalizable to regions outside Europe or to other physicians treating PD. Conclusion Around one-third of experts and, from their perspective, around two-thirds of patients are dissatisfied with the currently available PD treatment options.

Introduction Patients with Peyronie’s disease (PD) and erectile dysfunction (ED) concomitant with shortening or other malformations benefit from prosthesis implantation and penile lengthening procedures. Aim To evaluate the safety and efficacy of a multi-incisional technique with penile prosthesis implantation with multiple corporeal incisions and collagen grafting for the surgical management of complex cases of PD with ED and severe penile shortening. Methods From February 2015–May 2018, 43 consecutive patients with complex PD were treated using this technique. Implantation of a penile prosthesis (malleable or inflatable [IPP]) together with multiple relaxing tunica albuginea incisions and grafting with a self-adhesive collagen-fibrin fleece (TachoSil, Baxter Healthcare) was performed in all patients by a single surgeon (J.I.M.S.). Main Outcome Measure Penile length and curvature correction, operative time, and incidence of postoperative complications were recorded as outcome measures. Functional outcomes were measured with questionnaires (International Index of Erectile Function-5, Erection Hardness Score, modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, PD Questionnaire) before and 3 and 6 months after surgery. Results With a median follow-up of 21 months (range 10–31), mean postsurgical penile lengthening was 2.5 (range 1–5) cm, with an improvement in the Bother domain of the PD Questionnaire of 4.4 (range 2–5) points. The average operative time was 86.7 and 71.6 minutes for the IPP and malleable penile prosthesis procedure, respectively. No glans ischemia was recorded; however, 1 IPP infection and 1 delayed distal corporeal erosion were recorded. Hematoma or bruising was observed in 23.2% of patients. The modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was completed by 39 (90.7%) patients. Overall, 89.7% would recommend this surgery. Patient satisfaction with straightness and length was 94.9% and 82.1%, respectively. Clinical Implications The described technique helps restoration of penile length and erectile function in patients with complex PD. Strengths & Limitations The strength of the study is that it offers a simple, easy-to-apply technique for surgeons to correct shortening and other malformations in patients with ED and complex PD. The study is limited by the small number of patients, the short follow-up period and the performance of the technique by a single high-volume implanter. Conclusion The implantation of a penile prosthesis (malleable or inflatable) together with multiple incisions of the plaque/tunica albuginea and grafting with a collagen fleece is a safe and efficient treatment for patients with complex PD in addition to ED and significant shortening.

Background Erectile dysfunction (ED) is a debilitating medical condition in which current treatments are minimally effective in diabetic patients due to neuropathy of the cavernous nerve, a peripheral nerve that innervates the penis. Loss of innervation causes apoptosis of penile smooth muscle, remodeling of corpora cavernosa (penile erectile tissue) morphology, and ED. Aim In this study, microarray and pathway analysis were used to obtain a global understanding of how signaling mechanisms are altered in diabetic patients and animal models as ED develops, in order to identify novel targets for disease management, and points of intervention for clinical therapy development. Methods and Outcomes Human corpora cavernosal tissue was obtained from diabetic (n = 4) and Peyronie’s (control, n = 3) patients that were undergoing prosthesis implant to treat ED, and BB/WOR diabetic (n = 5) and resistant (n = 5) rats. RNA was extracted using TRIzol, DNase treated, and purified by Qiagen mini kit. Microarray was performed using the Human Gene 2.0 ST Array. (i) Alterations in patient and diabetic rat pathway signaling were examined using several analytical tools (ShinyGO, Metascape, WebGestalt, STRING) and databases, (ii) Strengths/weaknesses of the different pathway analysis tools were compared, and (iii) Comparison of human and rat (BB/WOR and Streptozotocin) pathway analysis was performed. Two technical replicates were performed. P value (FDR) < .15 was used as threshold for differential expression. FDR < 0.05 was considered significant. Results Microarray identified 182 differentially expressed protein-coding genes. Pathway analysis revealed similar enrichments with different analytical tools. Down regulated pathways include development, tubular structure, sprouting, cell death, ischemia, angiogenesis, transcription, second messengers, and stem cell differentiation. ED patients, who have diabetes, incur significant loss of normal regulatory processes required for repair and replacement of injured corpora cavernosal tissue. Combined with loss of apoptotic regulatory mechanisms, this results in significant architectural remodeling of the corpora cavernosa, and loss of regenerative capacity in the penis. Clinical Translation This first report of microarray and pathway analysis in human corpora cavernosa, is critical for identification of novel pathways pertinent to ED and for validating animal models. Strengths and Limitations The analysis of tissue specific gene expression profiles provides a means of understanding drivers of disease and identifying novel pathways for clinical intervention. Conclusion Penis from diabetic ED patients lacks capacity for maintenance of corpora cavernosal architecture and regeneration, which are critical points for intervention for therapy development.

Background A total of 78 patients aged 11 to 17 years were diagnosed with congenital ventral penile curvature and underwent surgery with the dorsal plication technique between 2005 and 2014. Aim To investigate the long-term outcomes of 72 patients who underwent dorsal penile plication for the treatment of congenital ventral penile curvature without hypospadias. Methods In all cases, the intervascular space between the deep dorsal vein and dorsal artery was dissected, and tunical plication was carried out with non-absorbable 3-0 polyamide sutures and the complication and satisfaction rates of the patients were determined in the postoperative seventh year. Outcomes At the final postoperative follow-up, the patients’ satisfaction with the operation was found to be 95.8%. RESULTS Shortening of the penis (0.5-1 cm) in five cases, recurrence with less than a 20-degree curvature in two cases, palpable sutures in two cases was observed and no patients reported erectile dysfunction. Strengths & Limitations The limitations of our study can be considered as the absence of pharmacological erection in the preoperative evaluation, failure to evaluate penile length at the last postoperative follow-up due to the continued development of the penis, inability to evaluate erectile function at the beginning, postoperative erectile capacity being assessed in only some of the operated cases, all operations being performed by a single surgeon in the same center, and the absence of standardized questionnaires for postoperative satisfaction or adverse events. CONCLUSION According to the results of this study, dorsal plication is a relatively simple method with a low risk and high success rate for the treatment of congenital ventral penile curvatures.

Rationale Penile Prosthesis Implantation (PPI) is the definitive treatment for Erectile Dysfunction not responsive to conservative management strategies. Furthermore, it is a staple of surgical treatment of severe Peyronie’s Disease (PD) and phallic reconstruction. Expert implantologists occasionally face disastrous complications of penile implant surgery which can prove to be very challenging. In this article we present a selected number of case reports which exemplify this kind of situations and discuss management strategies while also commenting on plausible aetiologies. Patients’ concerns The first case describes a PPI performed in end-stage fibrotic corpora after multiple instances of implantation/explant. The second and third cases show two diametrically opposed approaches to the management of glans necrosis after PPI in post-radical cystectomy patients. The fourth case describes the history of a diabetic patient suffering from glandular, corporal and urethral necrosis after a complicated PPI procedure. The fifth case reports the surgical treatment of a case of recurring PD due to severe scarring and shrinking of a vascular Dacron patch applied in a previous operation. Diagnosis Complication diagnosis in all patient was mainly clinical, intra- and postoperative, with Penile Color Doppler Ultrasonography performed when needed in order to demonstrate penile blood flow. Interventions The patients underwent complex surgical procedures that addressed each specific complication. Complex penile implants with fibrosis-related complications, penile prosthesis explant with and without surgical debridement of necrotic areas, penile prosthesis explant with necrotic penile shaft and urethral amputation with perineostomy, and complex corporoplasty with scar tissue excision and patch application with PPI were performed in the five patients. Outcomes Penile anatomy and erectile function with PPI was achieved in 4 out of 5 patients. 1 of 5 patient is scheduled to undergo a total phallic reconstruction procedure at the time of this writing. Lessons Management of disastrous complications of penile implant surgery can be very challenging even in expert hands. In-and-out knowledge of possible PPI and PD complications is required to achieve an acceptable outcome.

Background Peyronie’s disease (PD) is a challenging clinical entity. To assist clinicians with diagnosis and management, four separate organizations have published PD guidelines over the past five years, but there remains a lack of consensus and data-driven recommendations for many aspects of diagnosis and treatment. Aim To compare and contrast PD guidelines, highlighting key similarities and differences among the guideline panel recommendations and identify areas for further research. Methods We performed an extensive review to compare and contrast diagnosis and treatment recommendations from publically available published PD guidelines from four different organizations: American Urological Association, European Association of Urology, Canadian Urologic Association, and the International Society of Sexual Medicine. Outcomes Key similarities and differences with regards to definition, evaluation, nonsurgical and surgical treatments were compared. Results Points of general consensus among the guideline panels included: History is adequate for diagnosis of PD, and intracavernosal injection is a gold standard to evaluate penile deformity prior to invasive intervention. Careful counseling with shared decision-making is required prior to treatment. In general, plication and incision and/or grafting surgery is reserved for patients with preserved erectile function whereas penile prosthesis implantation is the only surgical option for PD patients with erectile dysfunction. Overall, nonsurgical treatments have inferior evidence of efficacy with these being the main area of controversy; however, all societies recognize that intralesional injections may be used. 0Further research into the pathophysiology of PD may direct novel treatments targeted towards early intervention and rigorous outcomes research may direct best practices for the surgical treatment of PD in the future. Clinical Implications PD is a challenging clinical entity. Direct comparison of the published PD guidelines highlights clear standards of care as well as areas where more research is needed to promote higher levels of evidence-based practice. Strengths & Limitations To our knowledge this is the first report to directly compare and contrast published guidelines pertaining to the diagnosis and management of PD. Limitations include the lack of evidence-quality review pertaining to individual guideline recommendations, although this was not the aim of this review. Conclusion We highlight consensus of major urologic societies on many aspects of work up and management of PD with notable exceptions which may guide further research. Manka MG, White LA, Yafi FA, et al. Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation. J Sex Med 2021;18:363–375.

Background A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie’s disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial. Aim To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854). Methods A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD. Outcomes The primary outcomes are safety, penile length, penile curvature, Peyronie’s Disease Questionnaire, International Index of Erectile Function, and satisfaction. Results 6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7–2.0 cm) and curvature improvements (18–20%). PTT-to-PTT men also achieved additional length (0.6–0.8 cm) without further curvature improvements. An as-treated analysis of PTT use ≥15 minute/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18–21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie’s Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0–2.2 cm), and 61% had curve improvements (16.8–21.4° [32.8–35.8%]). RestoreX was preferred 3–4:1 over all other PD treatments, and 100% preferred it over other PTT devices. Clinical Implications Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs. Strengths & Limitations Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3–9 hours) treatment arm. Conclusion PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD.

Background Some studies showed encouraging results on the efficacy and safety of penile traction therapy after Peyronie's disease (PD) surgery. The early traction therapy (ETT) could be an effective and safe approach to minimize penile shortening in patients undergoing PD surgery. Aim To evaluate the feasibility, efficacy, and safety of a novel penile splint as ETT in patients with PD undergoing grafting techniques. Methods Patients with PD underwent plaque incision and grafting technique; at the end of the procedure, a novel penile splint (ETT) was applied to all patient. The device consisted of 2 10CH intubating stylets, self-adapted to each patient, that kept the penis stretched with the aid of non-absorbable sutures. The total expense for the materials needed to build each penile splint was less than 15 euros. This active traction was maintained for 1–3 weeks; then, we removed the stitches leaving the device on-site for a passive traction. Within 3–4 weeks from surgery, the penile splint was replaced by a standard penile traction device. Outcomes The main outcomes evaluated at 6 months included stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse. Results A total of 46 patients were enrolled. The median preoperative IIEF-EF, penile curvature, and SPL were 27 points, 70°, and 13 cm, respectively. The median follow-up was 15 months. The median postoperative IIEF-EF was 25 points (P < .001). The median residual penile curvature was 10° (P < .001). The median postoperative SPL was 13 cm (P = .269). 8 patients (17.4%) lost 1 cm of SPL; no shortening greater than 1 cm was recorded. The median time to first satisfactory sexual intercourse and patient satisfaction score was 6 weeks and 9 points, respectively. Clinical Implications Our results could pave the way for a new line of research, which in turn could lead to an improvement in the postoperative management of the patient undergoing surgery for PD. Strength & Limitations This is the first study evaluating the ETT after PD surgery. The main limitation of this study is the lack of a randomized control group. Other weaknesses are the small sample size and the short follow-up time. Conclusion Our novel penile splint is inexpensive, easy to assemble, and adaptable to the patient. ETT using this novel device, followed by standard traction therapy, seems to be feasible, effective, and safe.

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 (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.

Background Penile prosthesis implantation in cases of severe Peyronie’s disease may require plaque excision/incision and grafting, which may require mobilization of the neurovascular bundle or urethra, posing the risks of penile hyposensitivity or urethral injury, and is time-consuming, possibly increasing infection risk. Aim Evaluating transcorporeal debulking of Peyronie’s plaques by “Shaeer’s punch technique.” Methods Penile prosthesis implantation and punch technique (PPI-Punch) was performed for 26 patients. After corporotomy and dilatation, Peyronie’s plaques were punched out from within the corpora cavernosa using the punch forceps, and then a penile prosthesis was implanted. Comparison to a matching retrospective group of 18 patients operated upon by plaque excision-grafting and penile prosthesis implantation was performed. Outcomes The study outcomes were straightness of the erect penis, complication, satisfaction with length on a 5-point scale, the International Index of Erectile Function-5, and the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire. Results Average preoperative curvature angle was 58.1 ± 11.7 in the Punch group and 58 ± 14.8 in the excision-grafting group, p=0.99. After surgery, all patients had a straight penis. No tunical perforations, urethral injuries, or extrusions were noted. Average additional operative time for Punch technique ranged from 5 to 10 minutes (7.3 ± 1.7), in contrast to the excision-grafting group where plaque surgery duration was 50.8 minutes ± 11.1, an 85% difference, p < 0.0001. Septal plaques in the latter group could not be removed. In the PPI-Punch group, penile sensitivity was preserved in all patients, compared with the excision/grafting group, with 7 of 18 patients reporting hyposthesia of the glans. Infection occurred in 1 of 26 patients in the PPI-Punch group, compared with 2 of 18 patients in the excision/grafting group. Satisfaction with length on a 5-point scale was 3.8 ± 0.9 in the punch group, versus 3.1 ± 1.1 in the excision-grafting group, p=0.009. Clinical Implications The proposed technique is minimally invasive and prompt, possibly decreasing the known complications of plaque surgery and PPI including sensory loss. Strengths & Limitations One limitation is the inability to accurately measure preoperative erect length in patients with erectile dysfunction with poor response to intracavernous injections. Conclusion Shaeer’s punch technique is a minimally invasive procedure for transcorporeal excavation of Peyronie’s plaques before penile prosthesis implantation, omitting the need for mobilization of the neurovascular bundle or spongiosum, and hence, there is low or no risk for nerve or urethral injury and brief plaque surgery time.

Background Peyronie’s disease, diabetes, trauma, pelvic surgeries, and aging are conditions that promote penile fibrosis and trigger erectile dysfunction associated with penile reduction. These pathologies require an objective preoperative diagnosis and intraoperative management of penile shrinkage. Aim The goal is to develop a non-grafting procedure to promote lengthening using geometric patterns of multiple staggered small cuts on the tunica albuginea with an optimal ratio between tissue expansion and resistance to confine the cylinders inside the corpora cavernosa. Methods Between February 2016 and February 2019, 416 patients suffering penile shortening with or without Peyronie’s disease received implants using the tunica expansion procedures (TEP). Incisions were distributed in respective areas of the tunica to allow maximum expansion while maintaining strength to confine prosthetic cylinders within the corpora cavernosa to prevent bulges and denting. Outcomes In accordance with these principles, surgical objectives and patient satisfaction were achieved in length and girth restoration regardless of the type of implant used to obtain adequate axial rigidity. Results The sample of 416 patients included 287 cases of Peyronie’s disease having a mean axial deviation of 51° (0–90°) whose curvature was corrected in surgery, with pressure from the cylinders maintaining straightness for malleable and inflatable devices. Tunica constriction in 40.86% of cases was corrected with vertical relaxing incisions. Ventral glanspexy was performed intraoperatively in 92.8% of patients to prevent hypermobility. A penile gain of 3.3 cm (2–6) was measured intraoperatively. Clinical Implications Diagnosis of penile shortening was performed by a stretch length test and pharmacologically induced erection together with the patient’s subjective opinion of penile loss. Lengthening procedure depends on the limit of the dissected neurovascular bundle. The patient and surgeon select the type of implant in accordance with his individual anatomic characteristics. Strengths and Limitations The TEP strategy is a non-grafting procedure based on tissue restitution by expansion instead of substitution, which provides surgeons a solution for penile enlargement to the limit of the dissected neurovascular bundle. Conclusions The TEP strategy has been demonstrated to be safe and effective to resolve problems of penile size reduction independently of penile curvature. It eliminates grafting and improves penile lengthening techniques using small, staggered cuts on the tunica albuginea, while maintaining tunica structural resistance to contain cylinders inside the corpora, preventing bulges and denting, facilitating tissue regeneration, and improving axial rigidity.

Background An accurate curvature assessment (CA) is required in the decision-making process for patients with Peyronie’s disease. In-office CA following induced erection is the gold standard for CA, although penile photography is commonly used due to its convenience. Camera deviations during 2D image acquisition might affect CA accuracy. Aim To investigate the impact of camera angle deviations on CA. Methods 2D pictures were taken from 5 models with a known uniplanar curvature (40°, 45°, 60°, 90°, and 120°). The model was kept on a fixed point and the camera was rotated around it. Pictures were taken with every 10° increase in camera deviation from the optimal position. The camera rotated to a maximum of 90° deviation in both the vertical and horizontal planes. The pictures were analyzed by 2 different urologists using a goniometer. The expected apparent curvature (AC) and the corresponding picture assessment error (PAE = AC – real model curvature) were also calculated for each picture using trigonometry principles. Main Outcome Measure Assessing PAE magnitude and patterns was our primary outcome. Secondary outcomes were intraobserver, interobserver, and observer-AC intraclass correlation coefficient (ICC). Results 100 pictures were analyzed. Intraobserver reliability was high (ICC = 0.99) for both urologists. Interobserver and observer-AC correlation were also high (ICC = 0.996 and ICC = 0.992, respectively). When the camera rotated in the horizontal axis, the PAE underestimated the curvature for models with curvatures smaller than 90° and overestimated the reading of the 120° model. When the camera rotated in the vertical axis, PAE had an inverse effect. The PAE showed a tendency to increase exponentially with higher deviation, reaching almost 100% for a deviation of 80°. Nevertheless, analyzing its magnitude regardless of the curvature, PAE was always Clinical Implications If using picture-based CA, clinicians should attempt to take a picture perpendicular to the curvature plane for the most accurate measurement in degrees. Many clinicians request that patients take 3 pictures in a standard fashion (craniocaudal, lateral, and frontal), and if this technique is to be used, an extra picture is recommended. Strength & Limitations In our controlled environment, we were able to isolate CA errors due to camera angles from other confounders such as erection hardness. As a consequence, however, our results cannot be easily generalized. Conclusion PAE due to non-optimal camera position is a complex phenomenon that affects CA depending on the rotation axis and the degree of penile curvature. Nevertheless, PAE is always

Introduction Plaque incision and grafting (PIG) for Peyronie’s disease (PD) is not devoid of complications such as erectile dysfunction and penile sensory changes. Aim To define the rate and chronology of penile sensation loss after PIG surgery and to define predictors of such. Methods The study population consisted of patients with PD-associated penile curvature who underwent PIG surgery with at least 6 months of follow-up. Demographics and PD factors were recorded. Patient had preoperative assessment of penile sensation and deformity. Postoperative follow-up occurred at 1 week, 1 month, 6 months, and 1 year after surgery. Neurovascular bundle elevation was conducted with loupe magnification. Main Outcome Measure Penile sensation was evaluated with a biothesiometer and graded on a patient-reported visual analog scale (0–10) in which 0 defined a completely numb area and 10 defined perfect sensation. The degree of sensation loss was defined as extensive (any 1 area >5 cm), major (2–5 cm), and minor (≤2 cm). The penile sensation loss distribution was defined as focal (1 site) or diffuse (>1 site). Results 63 patients were analyzed. Mean age was 56 ± 10 years. Mean duration of PD at the time of PIG was 15 ± 7 (12–38) months. 75% had curvature alone, and 25% had hourglass/indentation deformities. Mean primary curvature was 64˚ ± 28˚. The mean operation duration was 3.5 ± 1.8 hours. 21% had some degree of sensation loss at 1 week, 21% at 1 month, 8% at 6 months, and 3% at 12 months. Only 1 patient (1.5%) at 2 years continued to have extensive sensation loss on the glans and distal shaft with a very elevated sensitivity threshold. Using multivariable analysis, the only predictor of penile sensation loss ≥6 months was a duration of operation >4 hours (odds ratio = 2.1; 95% confidence interval = 1.2–3.0; P < .01). Clinical Implications The study highlights the need during patient consent to discuss penile sensation loss. Patients should be informed that rates of penile sensation loss ranges from 2-30% and most patients will have complete resolution of any sensation loss within one year of follow-up. Strength and Limitations To our knowledge no other studies have described the chronology and severity of penile sensation following PIG, our study demonstrates the utility of biothesiometry in measuring penile sensation before and after PIG. Number of patients and absence of control group represent a limitation. Conclusion Sensation loss is not uncommon after PIG surgery. It decreases in frequency and severity with time with only rare cases occurring >12 months. Longer operations appeared to be more likely associated with sensation loss.

Background Adjuvant maneuvers are often necessary to correct residual curvature during inflatable penile prosthesis (IPP) placement in patients with Peyronie's disease (PD). Aim We present our multicenter experience using collagen fleece as graft material for plaque incision and grafting (PIG) during IPP placement in patients with moderate to severe PD. Methods We retrospectively reviewed 51 patients with IPP from 3 sites who underwent PIG with Tachosil (Baxter, IL) collagen fleece. Coloplast (Minneapolis, MN) IPP devices were used. Factors associated with residual curvature, revision, and patient satisfaction were performed using chi-squared analysis. Outcomes We evaluated postoperative outcomes including factors associated with residual curvature, revision, and patient satisfaction. Results The mean compound curvature was 69.6°. The mean follow-up was 10.6 (range 1–38) months. All patients reported erections sufficient for penetrative intercourse at the last follow-up. Residual curvature Clinical Implications In our multicenter study, patients experienced substantial curve correction with minimal complications, and in the few patients who had persistent mild curvature, severe preoperative curvature (>60°) was found to be the only risk factor. Strengths & Limitations Our study represents the largest series of patients coming from multiple centers undergoing surgical correction of PD with IPP and collagen fleece grafting. Limitations of this study include the retrospective study design, lack of a comparison group, and modest follow-up. Conclusion PIG using collagen fleece is a safe and effective means of correcting residual curvature after IPP placement in patients with moderate to severe PD.

Background The subsequent health risks associated with Peyronie’s disease (PD) are unknown. Aim This cohort study assesses the risk of developing auto-immune conditions and common chronic health conditions after a diagnosis of PD. We hypothesize that an increase in auto-immune disease will be evident in men with PD, as has been suggested in smaller studies. Methods We determined the longitudinal incidence of 13 auto-immune diseases and 25 common chronic conditions in a cohort from the Truven Health Analytics (Ann Arbor, Michigan, USA) database from 2007–2013. The cohort included men with 1 of 3 exposures in 2007: (1) men with PD, (2) men with erectile dysfunction (ED) but not PD, and (3) men without PD or ED, matched on age and follow-up duration. Outcomes To assess incidence, we utilized a Cox regression model adjusting for age, smoking, obesity, health care visits per year, urology visits per year, and years of follow-up. Results We included 8,728 men with PD; 204,147 men with ED; and 87,280 controls. Men with PD had an increased risk of developing benign prostatic hyperplasia (hazard ratio [HR] 1.21, 95% CI 1.16–1.27), prostatitis (HR 1.21, 95% CI 1.12–1.31), and lower urinary tract symptoms (HR 1.10, 95% CI 1.05–1.16) when compared to both men with ED and age-matched controls without ED or PD even when controlling for the number of urology visits per year. Compared to controls, men with PD also had an increased risk of developing keloids. No significant risk for any auto-immune disease was observed. Clinical Implications Clinicians should have heightened awareness for these relevant co-morbidities when treating men with PD. Strengths & Limitations Utilizing a claims database provides one of the largest cohorts of men with PD ever published but claims databases lack some individual patient data such as risk factors and demographic information relevant to PD, including: penile injury, history of urologic procedures, and other lifestyle factors. Conclusion Men with PD had a higher risk of benign prostatic hyperplasia, lower urinary tract symptoms, prostatitis, and keloids after a diagnosis of PD, but no increased risk of auto-immune conditions. These findings suggest a common etiology for these conditions that may manifest itself in diseases at different times in men’s life cycle.

Background There are limited data in the literature that describe the management of Peyronie's disease (PD) with severe compound curvature, which often requires additional straightening procedures after plaque excision and grafting (PEG) to achieve functional penile straightening ( Aim This study highlights the clinical distinction and our experience with men with PD and severe compound curvature treated with PEG and supplemental tunica albuginea plication (TAP). Methods We performed a retrospective chart review of patients with PD and acute angulation who underwent PEG (group 1) and patients with compound curvature who underwent PEG with TAP (group 2) between 2007 and 2016. Outcomes Primary post-operative outcomes of interest include change in penile curvature, change in measured stretched penile length, and subjective report on penile sensation and sexually induced penile rigidity. Results 240 Men with PD were included in the study, of which 79 (33%) patients in group 1 underwent PEG and 161 (67%) in group 2 underwent PEG and TAP. There was no difference in associated PD co-morbidities including age, hypertension, hyperlipidemia, hypogonadism, diabetes, or tobacco use. After artificial induction of erection with intracorporal trimix injection, the average primary curvature was 73 (range, 20–120) degrees for group 1 compared to 79 (range, 35–140) degrees for group 2 (P = .01). Group 2 had an average secondary curvature of 36 (20–80 degrees). After completion of PEG, men in group 2 had an average residual curvature of 30 (range, 20–50) degrees which required 1–6 TAPs to achieve functional straightness ( Clinical Translation Our review shows promising surgical outcomes for the use of PEG and supplemental TAP for this subtype of complex PD. Strengths and Limitations This article reports the largest experience with treatment of PD with compound curvature to date. Limitations of this study include the retrospective nature of the analysis as well as the lack of a validated objective measurement of erectile function after penile straightening. Conclusion Our study found no baseline difference in underlying co-morbidities in men with severe compound curvature compared with men with acute severe angulated curvature. Men with severe compound curvature represent a severe and under-recognized population of men with PD who can be surgically corrected with PEG and supplemental TAP(s) when needed without an increased risk of loss of penile length, recurrent curvature, decreased penile sensation, or erectile dysfunction when compared to men treated with PEG alone.

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.

Background Despite published guidelines on Peyronie's disease (PD), there are limited data on actual surgical practice among surgeons. Aim To evaluate the surgical practice patterns in PD among surgeons from different continents and members of various sexual medicine societies. Methods An anonymous survey on various pre-, intra-, and postoperative aspects of PD surgical care was distributed in printed format during International Society of Sexual Medicine meetings and as an online survey to International Society of Sexual Medicine members. Outcomes 390 surgeons responded to the survey, with great variations in pre-, intra-, and postoperative strategies in PD surgical care. Results Most surgeons performed fewer than 10 penile plications and 10 graft surgeries per year. Modified Nesbit plication was the preferred option by most surgeons. Surgeons who received fellowship training were more likely to perform autologous than allograft surgery (odds ratio = 1.79, 95% CI = 1.13–2.82, P = .01). The use of penile color duplex ultrasound was inconsistently performed, with higher-volume surgeons (ie, >20 cases operated a year) more likely to use this diagnostic modality (odds ratio = 70.18, 95% CI = 20.99–234.6, P < .001). Most surgeons agreed that surgical intervention should be performed only after a 6-month history of stable penile curvature, although higher-volume surgeons were more inclined to perform surgery sooner (P = .08). Clinical Implications Although it is unknown whether variations in PD surgery significantly affect clinical outcome and patient satisfaction rate, this worldwide survey study has the potential to assist in the formation of a new practice guideline and serve as the basis for future prospective multinational studies. Strength and Limitations This is one of the largest surveys on PD practice and, to our knowledge, the only survey conducted across various sexual medicine societies, with the inclusion of many high-volume and experienced PD surgeons. This also is the 1st study to comprehensively evaluate many key aspects in surgical practice patterns for PD. However, the categorization on the questionnaire used in this survey was not designed to allow for direct comparison given the possibility of some surgeons with dual society memberships, reporting biases, large CIs in outcomes, different patient demographics, and cultural acceptance. Conclusion There is great variation in surgical practice patterns in PD management, including key differences among surgeons across different continents and sexual medicine societies.

Background Correction of residual curvature during inflatable penile prosthesis (IPP) implantation in patients with Peyronie's disease (PD) by plaque incision and grafting is a common approach. Aim To present a novel technique for residual curvature correction during IPP implantation using collagen fleece (TachoSil, Baxter Healthcare Corp, Deerfield, IL, USA). Methods After the IPP (Titan Touch, Coloplast, Minneapolis, MN, USA) is placed, the implant is inflated maximally. When residual curvature exceeds 40°, the PICS (penile implant in combination with the Sealing technique) technique is performed. The device is deflated, and a circumcising skin incision and penile degloving are performed. After elevation of the neurovascular bundle, the device is reinflated maximally. Plaque incision is performed at the point of maximum curvature using electrocautery. This leads to penile straightening because the tension is removed. In the next step, the defect of the tunica is closed with collagen fleece, which sticks to the tunica and defect without any sutures needed. The neurovascular bundle is reapproximated and the Buck fascia is closed. This is followed by closure of penile skin. Outcomes Primary outcome measurements were straightening rates, operative times, 5-item International Index of Erectile Function (IIEF-5) scores at follow-up, immediate and late complications, and patient satisfaction. Results The PICS technique was applied to 15 patients. Mean patient age was 61.7 years (52–79 years). Mean residual curvature after IPP was 66.7° (50–90°). Mean operative time was 117.3 minutes (100–140 minutes). Mean follow-up was 15.1 months (1–29 months). 12 of 15 patients (80%) showed a totally straight penis. 3 patients (20%) had residual curvature of 10° at follow-up, which did not interfere with sexual intercourse. Mean IIEF-5 score at follow-up was 24.2 (22–25). No immediate or late complications occurred. All patients were satisfied with the surgical outcomes. Clinical Implications This novel technique prevents puncture or injury of the device, because the collagen fleece does not require suture fixation into the defect after plaque incision. Strengths and Limitations This technique can be applied to patients with severe PD who display residual curvature greater than 40° after IPP placement. It is a fast approach with low complication rates. Limitations include the small patient population and short follow-up. Conclusion The PICS technique represents a safe and time-saving approach for residual curvature correction during IPP placement in patients with PD and prevents device puncture.

Background Patients with severe erectile dysfunction (ED) and penile size issues, especially seen in Peyronie's disease (PD), are candidates for more invasive penile prosthesis insertion techniques that aim for penile length and girth reconstruction. Aim To present the feasibility and safety of penile length and girth restoration based on the so-called multiple-slit technique (MUST) for patients with severe ED and significant penile shortening with or without PD. Methods From July 2013 through January 2016, 138 patients underwent the MUST. The International Index of Erectile Function (IIEF) and the Erectile Dysfunction Inventory of Treatment Satisfaction were completed. Outcomes Outcome analysis was focused on penile length restoration, penile curvature correction, intra- and postoperative complications, and patient satisfaction. Results 138 patients underwent the procedure (103 malleable and 35 inflatable devices). Etiologies of penile shortening and narrowing were PD, severe ED, post-radical prostatectomy, and androgen-deprivation therapy with or without brachytherapy or external radiotherapy for prostate cancer, and post-penile fracture in 60.1%, 24.6%, 10.1%, 3.6%, and 2.2%, respectively. In PD cases, the mean deviation of the penile axis was 55° (range = 0–90°). Mean subjective penile length loss reported was 3.2 cm (range = 1–5 cm), and shaft constriction was present in 44.9%. Median follow-up was 15.2 months (range = 6–36 months). Mean penile length gain was 3.1 cm (range = 2–5 cm). No penile prosthesis infection caused device explantation. One glans necrosis was encountered. The average IIEF score increased from 22 points at baseline to 66 points at 6-month follow-up. Clinical Implications The MUST helps address penile size issues in cases of severe ED with concomitant conditions that impair penile length or girth. Strengths and Limitations The strength of the study is its applicability to provide surgeons with a solution for cases in which patients have severe ED and penile size impairment owing to underlying conditions such as PD. The study is limited by the relatively short follow-up. Conclusions The MUST is an effective, safe, and viable treatment option for a selected patient cohort. Because of the potential complications, proper counseling should take place and only experienced surgeons should perform this type of surgery.

Background Penile traction therapy with the use of a traction device (TD) or vacuum erectile device (VED) has been studied as local modalities for Peyronie’s disease (PD). Aim To identify changes of penile curvature, erectile function, and possible cellular and molecular mechanisms between the TD and VED in a rat model of PD. Methods Peyronie’s plaque was induced in 30 adult male rats. Then, rats were randomly divided into control (PD without treatment), VED, and TD groups. In the VED group, vacuum pressure was applied to the cylinder to induce penile engorgement inside the cylinder for 1 minute. The penis was allowed to deflate completely for another 1 minute. This was repeated for five cycles (inflate and deflate). In the TD group, the rat penis was straightened by a suspended tension gauge at the same tension by clamping the prepuce. This was performed three times per day at 20 minutes per session, with 5-minute intervals between sessions. The entire treatment duration was 4 weeks. Outcomes Penile curvature, intracavernosal pressure, and mean arterial pressure were measured. Immunohistochemistry for α-smooth muscle actin, transforming growth factor-β1 and mothers against decapentaplegic homolog 2/3 were performed. Results The TD and VED groups had less penile curvature compared with the control group (15.3 ± 5.3° for TD, 28.4 ± 6.8° for VED, 38.6 ± 10.5° for control; P < .001 for TD vs control, P < .05 for VED vs control). The TD group also had less penile curvature compared with the VED group (P < .05). The VED group had a higher ratio of intracavernosal pressure to mean arterial pressure compared with the two other groups (0.56 ± 0.10 for VED, 0.38 ± 0.06 for TD, 0.32 ± 0.07 for control; P < .001). The immunohistochemistry results showed the VED group had more preserved α-smooth muscle actin with less transforming growth factor-β1 and mothers against decapentaplegic homolog 2/3 than the TD and control groups in the corpus cavernosa. Clinical Translation Various benefits can be observed with the TD and VED for the treatment of PD. Strengths and Limitations This study explored the mechanism and benefits of TD and VED therapies for the treatment of PD. The rat model might not represent the human condition. Conclusion Penile traction therapy with the TD or VED is beneficial to decrease penile curvature in animal models of PD. The underlying mechanism could be related to antiapoptosis, antifibrosis, and smooth muscle preservation.

Introduction The initial clinical trials for intralesional collagenase Clostridium histolyticum (CCh) injection therapy for Peyronie disease (PD) excluded men on antiplatelet or anticoagulant medications except those on low-dose aspirin. Men with PD who take such medications present a challenging clinical scenario because of a lack of evidence regarding the safety of CCh while on these drugs. Aim To evaluate safety outcomes among patients continuing anticoagulant and antiplatelet therapy during ongoing intralesional CCh injection treatment for PD. Methods An institutional review board approved a database of 187 patients treated with CCh at an academic men's health practice from January 2016 through April 2019 was reviewed. Men on antiplatelet/anticoagulant medications were not instructed to stop these agents. Data on patient demographics, comorbidities, CCh injection details, use or nonuse of antiplatelet/anticoagulant medications, and adverse events were extracted from the electronic medical record. Rates of hematoma formation, bruising, swelling, and corporal rupture were determined. Univariate statistical analysis compared clinical data and adverse events between men on or off antiplatelet/anticoagulant medications. Main Outcome Measure Statistical comparison of adverse events in those taking or not taking antiplatelet or anticoagulant medications while undergoing intralesional CCh injection therapy for PD. Results Of 187 men undergoing CCh treatment, 33 (17.6%) were on concomitant antiplatelet or anticoagulant therapy. Aspirin 81 mg alone was the most common pharmacologic agent (58% of men on antiplatelet/anticoagulants); medications also included other antiplatelet drugs, warfarin, and novel oral anticoagulants (NOACs). Men taking blood thinners during intralesional CCh injection therapy experienced no statistical difference in rates of bruising, swelling, or hematoma formation compared with men not on antiplatelet/anticoagulants. No corporal ruptures were observed in either group. Men on antiplatelet or anticoagulant therapy were more likely to be older (64 vs 58 years old, P = 0.005), have hypertension (P = 0.025), and have hyperlipidemia (0.009). Clinical Implications Intralesional CCh injection therapy may be offered to men on antiplatelet/anticoagulant medications without increased risk of adverse events. Strength & Limitations This study evaluated the experience of a single surgeon, with a systematic evaluation of adverse events captured in a robust electronic medical record. The retrospective nature of this study limits conclusions but builds upon work performed in the initial clinical trials for CCh. Conclusion Our findings suggest that antiplatelet and anticoagulant medications do not increase the risk of adverse events during intralesional CCh injection therapy for PD.

Background Traditionally, surgery has been considered the gold standard treatment for Peyronie’s disease (PD). Less-invasive alternatives, such as collagenase Clostridium histolyticum (CCH) and traction therapy, have been proposed and proven effective. Aim To compare cost-effectiveness of management options for PD. Methods A Markov analytic model was created to compare the cost-effectiveness of treatment with a novel traction device, RestoreX (RXPTT), vs CCH vs surgery. Outcomes were derived from single-institution, prospective data of 63 men treated with RXPTT, 115 with CCH, and 23 with plication or incision and grafting. Costs were based on 2017 Medicare reimbursement and utility values from the literature. Main Outcome Measures Model outcomes included complications for each treatment arm, as well as the probability of success, which was defined as ≥20% improvement in curvature. Univariable and multivariable sensitivity analyses were performed to test the robustness of the model. Results Overall success rates were 96% (surgery), 66% (CCH), and 48% (RXPTT). At 10 years after treatment, RXPTT was the most cost-effective, with mean costs per patient of $883 (RXPTT), $11,419 (surgery), and $33,628 (CCH). CCH and surgery both resulted in a gain of quality adjusted life years (QALYs) relative to RXPTT (9.44 and 9.36 vs 9.27, respectively). Sensitivity analysis demonstrated greater cost-effectiveness for surgery if lower (≤46%) rates of postoperative erectile dysfunction or length loss (≤3%). CCH became more cost-effective at lower costs (≤$16,726) or higher success rates (≥76%). On multivariable sensitivity analysis at a willingness to pay threshold of $100,000/QALY, the most cost-effective strategy was RXPTT in 49%, surgery in 48%, and CCH in 3% of simulations. At a willingness to treat threshold of $150,000/QALY, the most cost-effective treatment option was RXPTT in 33%, surgery in 55%, and CCH in 12% of simulations. Clinical Implications In an era of value-based care, this model can guide cost-effective treatment selection on the basis of provider, patient, and payer characteristics. Strengths & Limitations The current study represents the first cost-effectiveness comparison of treatment modalities for PD and is strengthened by prospective data collection, large CCH and traction sample sizes, and robust sensitivity analyses. Consistent with cost-effective models, the model is limited by assumptions and may not apply to all scenarios. Conclusions RXPTT represents a more cost-effective method for achieving ≥20% curvature improvement compared with surgery or CCH. Depending on treatment goals, rate of surgical complications, and willingness to pay threshold, surgery and CCH may become more cost-effective in select scenarios.

Background Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie’s disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. Aim To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. Methods A prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). Outcomes Changes in penile length, curvature, and subjective perception and the occurrence of adverse events. Results Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups. Clinical Implications Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. Strengths & Limitations Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. Conclusion The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices.

Introduction Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. Aim To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. Methods A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. Main Outcome Measures This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. Results In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. Conclusion A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies.

Introduction The surgical treatment of disorders of male sexual function requires specific exposure to correct the underlying problem safely and efficiently. Currently, sub-coronal exposure is used for treatment of phimosis, Peyronie's disease plaque (PDP), and semirigid penile prosthesis insertion. Infra-pubic and scrotal incisions are used for inflatable penile prosthesis (IPP) placement. However, men who present with several disorders might require multiple procedures and surgical incisions. Aim To report a prospective review of our surgical experience and outcomes with a single sub-coronal incision for IPP placement with a modified no-touch technique. This approach allows for access to the entire corporal body for multiple reconstructive procedures. Methods Two hundred men had IPPs placed through a sub-coronal incision using our modified no-touch technique. The penis was degloved to the level of the penoscrotal junction and the dartos muscle was everted and secured to the drapes. This allowed exclusion of the scrotal and penile skin from the operative field. After artificial erection, the patient's corpora were inspected for PDP and other abnormalities. Penoscrotal IPP models were placed in all cases with insertion proximal to the penoscrotal junction. After placement of the IPP, the abnormalities were repaired. Main Outcome Measures Feasibility of the procedure, operative times, complication rate, utilization of accessory, reconstructive procedures, and post-operative penile length. Results Of the 200 men who had IPP placement, 92 had PDP that was treated, 106 (53%) consented to circumcision, 24 (12%) had their reservoir placed ectopically, and 31 (16%) had a prosthesis exchanged through the sub-coronal technique. Mean operative time was 73 minutes (39–161 minutes). Conclusion Specialists in the surgical treatment of disorders of male sexual function can perform multiple procedures safely and easily through a modified no-touch single sub-coronal incision. This approach allows access to the entire corporal body, providing excellent visibility and allowing the surgeon to perform multiple penile reconstructive surgeries through a single incision.