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

Description

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.

Conditions

Peyronie Disease, Sexual Dysfunctions, Psychological, Genital Diseases, Male

Study Overview

Study Details

Study overview

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.

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

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

Condition
Peyronie Disease
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami - Desai Sethi Urology Institute, Miami, Florida, United States, 33136

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Be able to provide written informed consent
  • 2. Have a diagnosis of PD with evidence of stable disease as determined by the investigator
  • 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 and desire secondary treatment of penile curvature
  • 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. Patients with 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 investigation timeframe that will interfere with autologous PRP injection therapy.
  • 10. 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Thomas Masterson, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2025-01-15