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

Genital Diseases, Male Sexual Dysfunctions, Psychological Peyronie Disease

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

Inclusion Criteria6

Be able to provide written informed consent
Have a diagnosis of PD with evidence of stable disease as determined by the investigator
Patient must have palpable penile plaque
Penile curvature deformity of \>30° to \<90°
Agree to comply with all study related tests/procedures.
Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature

Exclusion Criteria10

Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
Previous history of priapism or penile fracture
PD characterized by a ventral plaque
Severe erectile dysfunction as characterized with an IIEF score ≤ 12
Hour-glass deformity
Unwilling to participate
Medically unfit for sexual intercourse as deemed by the principal investigator
Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.

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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.