Ziegelmann, Matthew J

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.

Objectives: To characterize 30-day morbidity of upper ureteral reconstruction (UUR) and lower ureteral reconstruction (LUR) surgery by comparing open and minimally invasive surgery (MIS) approaches using a national surgical outcomes registry. Methods: The American College of Surgeons National Surgical Quality Improvement Program database was reviewed for patients who underwent UUR and LUR between 2007 and 2017. Primary endpoints included 30-day complications, transfusion, readmission, return to operating room (ROR), and prolonged postoperative length of stay (LOS). Multivariable logistic regression was performed to observe the association of MIS approach on 30-day outcomes. Results: Three thousand forty-two patients were identified with 2116 undergoing UUR and 926 undergoing LUR. Of 2116 patients undergoing UUR, 1733 (82%) were performed through an MIS approach. On multivariable analysis, open approach for UUR was associated with increased odds of any 30-day complication (odds ratio (OR) 1.6 [1.1–2.4]; p = 0.014), major complication (OR 1.8 [1.04–3.0]; p = 0.034), transfusion (OR 3.7 [1.2–11.5]; p = 0.025), ROR (OR 2.0 [1.0–3.9]; p = 0.047), and prolonged LOS (OR 5.4 [3.9–7.6]; p < 0.001). Of the 926 patients undergoing LUR, 458 (49%) were performed through an MIS approach. On multivariable analysis, open approach for LUR was associated with increased odds of any 30-day complication (OR 1.5 [1.1–2.1]; p = 0.028), minor complication (OR 1.7 [1.1–2.6]; p = 0.02), transfusion (OR 8.1 [2.7–23.7]; p < 0.001), and prolonged LOS (OR 4.2 [2.4–7.3]; p < 0.001). Conclusion: Utilization of a national surgical database revealed an open approach was associated with increased 30-day morbidity across multiple postoperative outcome measures. These findings suggest an MIS approach should be considered, when feasible, for upper and lower ureteral reconstruction.

Abstract 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 (&gt;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.

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 &lt; .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.