Abstract

BackgroundPeyronie's disease (PD) is a chronic wound healing disorder, mainly involving tunica albuginea. Collagenase Clostridium Histolyticum (CCH) has shown its effectiveness in treating PD, but its efficacy and safety remain controversial, which propelled us to conduct the first evidence-based research on this topic.MethodsWe searched the Web of Science, PubMed, Embase, and ClinicalTrials.gov for related randomized controlled trials (RCTs). A systematic review and meta-analysis were performed to compare the penile curvature deformity (PCD), Peyronie's Disease Questionnaire peyronie's disease symptom bother (PDSB), penile pain score, total treatment-related adverse events (TAEs), and specific adverse events, including penile pain, penile edema, injection site pain, and contusion. Cochrane Collaboration's tool and Review Manager 5.3.0 version were applied, respectively, to evaluate the study quality and heterogeneity.ResultsFour articles (five RCTs) with 1,227 patients were finally included in the meta-analysis. The results revealed that CCH had excellent efficacy in relieving PCD (weighted mean difference [WMD]: −318.77, p < 0.001) and PDSB (WMD: −1.20, p < 0.001) compared to the placebo group, but there was no difference in the penile pain score (WMD: −0.64, P = 0.39) between the two groups. Furthermore, the incidence of TAEs in the CCH group was higher [odds ratio (OR): 12.86, p < 0.001].ConclusionsThe current evidence suggests that CCH has a significant effect on treating PD. Considering that all these adverse events are acceptable and curable, CCH could slow the disease progression in the acute phase or act as a substitute for patients unable or unwilling to undergo surgery. However, the conclusion could not be certainly drawn until RCTs with a larger scale proved it.

Highlights

  • Peyronie’s disease (PD), known as penile fibrous cavernositis, is a benign chronic disease characterized by the formation of fibroids in the tunica albuginea [1], leading to plaque formation, penile malformation, penile pain, sexual dysfunction, and mental disorders [2]

  • If correlative studies suffice to meet all the following criteria, they will be included in this study: [1] randomized controlled trials (RCTs) or pseudo-RCTs, [2] Males who were 18 years of age or older, had a regular heterosexual partner, and were clinically diagnosed with PD; [3] These RCTs investigated the effect of Collagenase Clostridium Histolyticum (CCH) in patients with PD and compared it with placebo or blank controls; and [4] The study provided at least one indicator of outcomes that can be analyzed

  • We looked for partial data available at the Cochrane Central Register of Controlled Trials according to the ClinicalTrials.gov Identifier of the three RCTs

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Summary

Introduction

Peyronie’s disease (PD), known as penile fibrous cavernositis, is a benign chronic disease characterized by the formation of fibroids in the tunica albuginea [1], leading to plaque formation, penile malformation, penile pain, sexual dysfunction, and mental disorders [2]. Clinical treatment of PD is mainly concentrated on the acute phase of the disease, aiming to prevent disease progression and penile malformation. For patients in the acute phase, non-surgical treatment is the primary choice, and only patients who are in the stable phase or with serious problems are treated with surgery [1, 6]. Peyronie’s disease (PD) is a chronic wound healing disorder, mainly involving tunica albuginea. Collagenase Clostridium Histolyticum (CCH) has shown its effectiveness in treating PD, but its efficacy and safety remain controversial, which propelled us to conduct the first evidence-based research on this topic

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