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

Last updated: January 21, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

4

Condition

Peyronie's Disease

Treatment

Collagenase Clostridium Histolyticum (CCH)

Clinical Study ID

NCT05777031
20221234
  • Ages 18-75
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Be able to provide written informed consent

  2. Have a diagnosis of PD with evidence of stable disease as determined by theinvestigator

  3. Patient must have palpable penile plaque

  4. Penile curvature deformity of >30° to <90°

  5. Agree to comply with all study related tests/procedures.

  6. Prior intralesional platelet rich plasma treatment within the past 18 months anddesire secondary treatment of penile curvature

Exclusion

Exclusion Criteria:

  1. Previous penile surgery of any kind (except circumcision and condyloma removal),such as penile lengthening, penile cancer surgery, penile plication, grafting,penile prosthesis.

  2. Previous intralesional injection therapy with CCH for PD within six months. Patientswith failed therapy greater than six months ago may be included.

  3. Previous history of priapism or penile fracture

  4. PD characterized by a ventral plaque

  5. Severe erectile dysfunction as characterized with an IIEF score ≤ 12

  6. Hour-glass deformity

  7. Unwilling to participate

  8. Medically unfit for sexual intercourse as deemed by the principal investigator

  9. Patients scheduled to undergo an elective medical procedure during the investigationtimeframe that will interfere with autologous PRP injection therapy.

  10. Have a serious comorbid illness/condition/behavior that, in the opinion of theinvestigator, may compromise the safety or compliance of the subject or precludesuccessful completion of the study.

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Collagenase Clostridium Histolyticum (CCH)
Phase: 4
Study Start date:
October 02, 2023
Estimated Completion Date:
January 15, 2026

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami - Desai Sethi Urology Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

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