Evaluating collagenase treatment for Peyronie's disease after PRP therapy
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
This study is testing if collagenase injections can help men with Peyronie's disease who have already tried platelet-rich plasma treatment to see if it improves their condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT05777031 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of collagenase clostridium histolyticum (CCH) injections in patients with Peyronie's disease who have previously received intralesional platelet-rich plasma (PRP) treatment. Participants will be assessed for the presence of penile plaques and curvature deformities, with a focus on understanding the side effects and overall effectiveness of CCH as a secondary treatment. The study aims to provide insights into the potential benefits of combining these two treatment modalities for improved patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with Peyronie's disease who have stable disease and have undergone prior PRP treatment within the last 18 months.
Not a fit: Patients with severe erectile dysfunction, previous penile surgeries, or specific plaque characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from Peyronie's disease, potentially improving their penile curvature and overall sexual function.
How similar studies have performed: While the combination of CCH and PRP is a novel approach, previous studies have shown success with CCH alone in treating Peyronie's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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. 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.
Where this trial is running
Miami, Florida and 1 other locations
- University of Miami - Desai Sethi Urology Institute — Miami, Florida, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Masterson, MD — University of Miami
- Study coordinator: Thomas Masterson, MD
- Email: tmasterson@med.miami.edu
- Phone: 305-243-4562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.