RecruitingPhase 4NCT05777031

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease


Sponsor

University of Miami

Enrollment

22 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the effectiveness of collagenase clostridium histolyticum (CCH, brand name Xiaflex) — an injectable enzyme that breaks down abnormal collagen tissue — in men with Peyronie's Disease who have already received intralesional platelet-rich plasma (PRP) injections. Peyronie's Disease is a condition where scar tissue (plaque) forms inside the penis, causing painful or curved erections that can make sexual intercourse difficult or impossible. PRP has been used as a first-line regenerative treatment to try to soften the plaque, and this study asks whether CCH injections afterward provide additional benefit. Adult men aged 18–75 who have confirmed stable Peyronie's Disease, a palpable penile plaque, penile curvature between 30 and 90 degrees, and have received PRP injections within the past 18 months are eligible. Previous CCH treatment more than 6 months ago is permitted. Men who have had penile surgery (other than circumcision), had a penile fracture or priapism, have ventral (downward-curving) plaque, have severe erectile dysfunction (IIEF score at or below 12), or have an hourglass deformity are excluded. Participants receive CCH injections with standardized follow-up measuring penile curvature, plaque characteristics, and patient-reported outcomes including sexual function. Peyronie's Disease is significantly underdiagnosed and undertreated despite affecting an estimated 1–9% of men — research into sequential treatment approaches helps define the best management pathway for this condition that profoundly affects men's physical and psychological wellbeing.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCollagenase Clostridium Histolyticum (CCH)

Injection of intralesional CCH (0.58mg) to the penile plaque at the point of maximal curvature. Second injection of each cycle will be injected 2-3mm apart from the prior injection.


Locations(2)

University of Miami - Desai Sethi Urology Institute

Miami, Florida, United States

University of Miami

Miami, Florida, United States

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NCT05777031


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