Levine, Laurence A.

Abstract Introduction Penile augmentation or penis enlargement surgery refers to any technique aimed at enhancing penile length or girth. These male enhancement surgical techniques can increase total penile length, either flaccid or erect, while others add to the penile shaft’s girth and/or glans size. Proposed strategies include physical methods such as various penile exercises, mechanical traction devices, and medical therapy, while surgical interventions include cosmetic and phallic reconstructive techniques and use of fillers, sleeves, grafts, and flaps to augment penile size. Objectives The International Consultation on Sexual Medicine (ICSM) consensus statements provide evidence-based recommendations and aim to guide a clinical framework in penile aesthetic and augmentation. Methods A comprehensive literature search was conducted to identify published literature relevant to penile augmentation or enhancement. Preliminary consensus was presented to the delegates attending the 5th ICSM meeting, and feedback was incorporated into the final document. Results Twenty new recommendations are provided with corresponding levels of evidence and grades of recommendation. Conclusions Due to the controversies and lack of longer-term data regarding penile augmentation and cosmetic procedures, comprehensive assessments and careful patient counseling weighing the pros and cons, as well as potential complications, are mandatory before embarking on any treatment. Surgeons should be experienced in anatomy and various surgical techniques, and it is important to individualize surgical options based on patient condition(s) and needs, surgeon expertise, and local resources.

Abstract Introduction There is no ideal treatment for Peyronie’s Disease (PD) since every patient has different needs with varying perceived risks versus benefits of individual treatment options, coupled with the degree of impact relating to PD on sexual function and beyond. Objectives The 5th International Consultation on Sexual Medicine (ICSM) guideline on PD provides an update to the previous ICSM with an aim to provide a clinical framework and best-evidenced consensus recommendations to assist clinicians in managing PD. Methodology Available literature was reviewed, and a modified Delphi consensus was undertaken by leading sexual medicine experts to achieve a set of Quality of Evidence and strength of recommendations. This guideline was developed as an authoritative best-evidenced consensus incorporating state-of-the-art knowledge and contemporary literature. Results A total of thirty-one recommendations were made on PD guidelines. New updates to the 4th ICSM on PD have been made in definition, pathophysiology, and treatment strategies. The presence of penile pain with erection could occur in the chronic phase due to torque or stretch on the penile scar and surrounding tissue. Oral therapy works best during the acute phase and should be provided concurrently with other treatment modalities. Penile traction therapy can reduce penile deformity as monotherapy or may be offered as part of a multimodal therapy approach. There is no convincing evidence supporting cellular-based therapy. The type of plication procedure used depends on the surgeon and patient preference, although excision of the tunica followed by plication may have a higher complication rate. There is currently no ideal graft, and graft contracture can occur postoperatively. Adjunctive procedures such as penile modeling, tunical plication, plaque incision/excision and grafting can be performed when penile deformity and/or penile curvature persist following penile prosthesis implantation. Conclusions The management of PD should be individualized based on the patient’s needs and preferences while balancing the benefits and risks of each treatment option.

Abstract Introduction The lower urinary tract injury, although often not life-threatening, can result in devastating long-term morbidity and, in some cases, permanent disability. Male genital trauma adversely affects male sexual function. Aim This 5th International Consultation on Sexual Medicine guideline on male genitalia trauma evaluates urologic trauma literature to guide clinicians in the best-evidenced management with specific emphasis on preservation and optimization of male sexual function. Methods A systematic literature search was conducted to identify relevant English-language publications and contemporary guidelines using the PubMed database (search dates January 1, 1990 to June 1, 2024) on the following terms: “trauma,” “penis,” “urethra,” “testis,” and “scrotum.” The available literature was discussed, and selected articles with the highest evidence available were used to create consensus guideline statements, categorized based on the Grading of Recommendations Assessment, Development and Evaluation system. In the absence of sufficient evidence, additional information was provided as a Clinical Principle or Expert Opinion. Results Fourteen recommendations are provided with corresponding levels of evidence and grades of recommendation. Conclusions Treating clinicians should be mindful that both the male genitalia trauma itself and treatment outcomes invariably affect various male sexual functions. Optimal treatment of male genitalia trauma is essential and should incorporate patient tolerances, needs, and preferences to minimize long-term sexual dysfunction.

Abstract Introduction Treatment recommendations for Peyronie's Disease (PD) differ based on whether a patient is in the acute/active versus chronic/stable phase of the disease, yet there are no agreed upon criteria for defining these clinical entities. Objectives To review the criteria used to define acute and chronic phase PD in modern PD intervention studies Methods We performed a search engine review to identify indexed publications for PD intervention studies and review articles / meta-analyses from the year 2011-2020. Outcomes results were catalogued and summarized across articles. As a result of the substantial heterogeneity of outcome measures and follow-up intervals, meta-analytic techniques were not applied to the data analysis. Results We identified a total of 104 studies that met inclusion criteria and had available information for review (n = 79 primary intervention studies; n = 25 review articles/meta-analyses/guidelines). Among the queried studies, we were unable to identify a consensus with respect to the criteria used to define acute and chronic phases of PD. 33% of primary intervention studies did not specifically define their criteria for acute and chronic phase PD, despite referencing these populations as part of the inclusion criteria in many instances. Studies used heterogenous criteria including total symptom duration, duration of “stable” symptoms, and presence/absence of pain. Conclusion Due to varying definitions across the literature, we were unable to create a standardized definition of acute and chronic phase Peyronie's in terms of time. Our findings emphasize the need for greater consensus in defining the treatment cohorts with future studies that assess treatment for men with PD.

ABSTRACTBackgroundDespite 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.AimTo perform a critical analysis of reporting quality in PD systematic reviews (SR) and meta-analyses (MA).MethodsStudy 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).OutcomesOutcomes 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.ResultsFrom 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 ImplicationsMany SR include markedly heterogenous levels of evidence and fail to meet accepted methodological criteria for reporting.Strengths and LimitationsMain 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.ConclusionMore high quality randomized controlled PD trials are necessary; SR and MA should focus on these studies alone.

ABSTRACTBackgroundCongenital penile curvature (CPC) is corrected surgically by various corporoplasty or tunica albuginea plication techniques, but the optimal surgical approach is not well-defined.AimTo 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.MethodsA 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.OutcomesObjective and subjective postoperative outcomes including penile straightening, shortening, penile sensory changes, and reoperation rates for both corporoplasty and tunica albuginea plication were summarized.ResultsFifty-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 <20˚. Reported rates of successful straightening ranged from 75 to 100% and 73 to 100% for plication and corporoplasty, respectively. A comprehensive and accurate assessment of surgical outcomes for CPC correction, such as satisfactory penile straightening, reoperation rates, glans sensory changes, and other complications was limited by significant inter-study heterogeneity with respect to the reporting of treatment outcomes.Clinical ImplicationsWhile 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 & LimitationsThis 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.ConclusionBoth 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.

Abstract Background Peyronie’s disease (PD) is characterized by penile pain, deformity, and sexual dysfunction, often resulting in an impaired sexual experience and significant psychological bother for the patient. However, there are limited data on the impact of PD on female sexual partners (FSPs). Aim To compare the psychosexual experience of men with PD and their FSPs. Methods We retrospectively reviewed all prospectively enrolled men and their FSPs who presented for initial PD evaluation to our sexual health clinic from July 2018 to February 2020. All men completed a PD-specific survey and the PD questionnaire (PDQ). If the patient was accompanied by an FSP during initial evaluation, she completed the PDQ for Female Sexual Partners and Female Sexual Function Index. We further queried our database that included information on patient demographics and clinical characteristics. Outcomes The main outcome of this study is retrospective comparison of responses with the PDQ and PDQ for Female Sexual Partners. Results Data were available for 44 men with PD (median age, 56 years; interquartile range, 49–63) and their FSPs (median age, 54 years; interquartile range, 50–61). The majority of men presented in the chronic phase (35 of 44, 79.5%), and median objective composite curvature was 75° (interquartile range, 50–90°). Owing to PD, female and male partners reported similar difficulty with vaginal intercourse (VI) (74.3% vs 81.5%, P = .555), decreased frequency of VI (70.6% vs 85.2%, P = .228), and at least moderate discomfort/pain with VI (48.6% vs 33.3%, P = .232). FSPs were “very” or “extremely” bothered by the appearance of their partner’s erect penis less often than male partners (20.0% vs 59.3%, P < .001). FSPs were “very” or “extremely” bothered by their partner’s PD during VI less often than men with PD (32.3% vs 65.2%, P = .017). Few FSPs (22.9%) had “severe” or “very severe” concern with damaging their partner’s penis during VI. Clinical Implications The sexual experience for men with PD and their FSPs differs, thus emphasizing the importance of active engagement of both men with PD and FSP during initial PD evaluation. Strengths and Limitations This initial study draws data from a single, high-volume men’s health clinic with a limited sample size. Survey responses may have been shared by patients with PD and their FSPs. Conclusion PD impacts the sexual experience for both men and FSPs. A similarly large proportion of men with PD and FSP noted decreased frequency of and difficulty with vaginal intercourse. Yet, FSPs were less bothered by the appearance of the erect penis and the deformity during VI compared with men.

AbstractPeyronie’s disease is a common yet poorly understood condition characterized by penile pain, curvature, sexual dysfunction and psychological bother. Peyronie’s disease represents a penile wound healing disorder, and is thought to arise from exuberant scarring in response to penile trauma in genetically predisposed men. In the absence of active treatment, the majority of men experience stable or worsening symptoms, with few reporting spontaneous resolution in penile curvature or other deformity. In contrast, penile pain improves or resolves in the majority of men. Treatment options vary based on symptom severity and stability. Several oral therapies are commonly prescribed, although to date there are no strong data to support any oral agents as monotherapy for Peyronie’s disease. Other options including penile traction therapy and intralesional injections result in modest improvements for many patients, particularly when used early after symptom onset. Penile straightening through approaches, such as penile plication and plaque incision or partial excision and grafting, represent the most rapid and reliable approach to correct penile curvature once the symptoms have stabilized. Side‐effects vary based on the type of surgery carried out, and include penile shortening, sensation changes and erectile dysfunction in the minority of men. In patients with drug refractory erectile dysfunction and Peyronie’s disease, placement of a penile prosthesis will address both issues, and is associated with high levels of patient satisfaction. The current review provides a practical approach to the modern evaluation and management of patients presenting with Peyronie’s disease.

Abstract 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 < .01, 95% confidence interval: 1.62–4.35). There were no associations between surgical complications and number of injections or CCH-associated adverse events. 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.

AbstractIntroductionPeyronie's disease (PD) is characterized by pain, deformity, sexual dysfunction, and psychological bother. Several treatments are available with varying levels of efficacy, and significant limitations exist with the currently available literature.AimTo explore modern-era methodological challenges inherent to PD research as they pertain to intervention studies.MethodsWe performed a critical review of the PD intervention literature to identify common methodological challenges with emphasis on aspects of patient assessment and treatment outcomes, study design, and statistical analysis. The key objective was to provide an impetus on which to build future research protocols, rather than focus on weaknesses with any individual studies.Main Outcome MeasureExpert opinion was used to summarize limitations with commonly reported objective outcomes such as penile curvature, girth, and length along with imaging modalities and objective questionnaires. Appropriate study design and statistical analysis were also reviewed to discuss common pitfalls in the PD literature.ResultsThere are multiple shortcomings inherent to studying objective PD outcomes such as penile curvature, girth, and length. These include lack of standardized protocols for preintervention and postintervention assessment, interobserver and intraobserver variability, and lack of consistent definitions for what defines an objective outcome as clinically “meaningful” for patients. Similarly, imaging studies including penile ultrasound are subject to marked variation, thereby limiting their utility to measure predefined primary or secondary study outcomes including cavernosal artery hemodynamics and penile plaque size. Objective and validated questionnaires such as the Peyronie's Disease Questionnaire and International Index of Erectile Function require that patients have recently engaged in sexual activity, which is challenging for many patients as a result of penile deformity with PD. Finally, careful study design and statistical analysis (including appropriate study power) are imperative to ensure reliable results. Current shortcomings in the majority of studies contribute to the low level of evidence available for most PD interventions.Clinical ImplicationsFuture PD intervention studies should focus on optimizing study design and statistical analysis. Furthermore, authors must incorporate standardized protocols for assessing preintervention and postintervention outcomes.Strength & LimitationsThe current analysis and recommendations for future study are based on the expertise and opinion of the manuscript authors.ConclusionMultiple areas of weakness in study design, statistical analysis, and patient outcomes assessment limit the reliability of data derived from PD intervention studies in the modern era. The global themes identified herein should serve as a basis upon which to build future research protocols.