New treatment approach for men with Peyronie's Disease using collagenase injections
Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease
PHASE4 · Charitable Union for the Research and Education of Peyronie's Disease · NCT06649539
This study is testing a new way to give collagenase injections to men with Peyronie's Disease who haven't had success with other treatments, to see if it helps improve their condition and includes feedback from their partners.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charitable Union for the Research and Education of Peyronie's Disease (other) |
| Locations | 1 site (Orem, Utah) |
| Trial ID | NCT06649539 on ClinicalTrials.gov |
What this trial studies
This study evaluates a modified protocol for administering collagenase Clostridium histolyticum (CCH) injections in men with Peyronie's Disease who have not responded to previous treatments. Participants will receive up to four series of CCH injections, complemented by mild in-office modeling and daily use of RestoreX and sildenafil. If patients are unsatisfied with their results after the initial series, they may enter a salvage phase for additional treatment. The study also involves the participation of sexual partners who will provide feedback on their support for the treatment.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with Peyronie's Disease, a curvature of 30 degrees or more, and the ability to achieve an erection satisfactory for intercourse.
Not a fit: Patients who have previously undergone surgical treatment on the penis or have had prior CCH injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for men suffering from Peyronie's Disease.
How similar studies have performed: Previous studies have shown efficacy with collagenase injections for Peyronie's Disease, making this approach a continuation of established treatment methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men with Peyronie's Disease * Older than 18 years old * Curvature ≥30 degrees * Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors * The patient exhibits a palpable plaque consistent with Peyronie's Disease * For partners, the only inclusion criteria is being willing to complete a questionnaire Exclusion Criteria: * Prior surgical treatment on the penis (other than circumcision) * Prior treatment with CCH injections * Any contraindications to CCH - as determined by the PI
Where this trial is running
Orem, Utah
- Male Fertility and Peyronie's Clinic — Orem, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Landon Trost, MD — Charitable Union for the Research and Education of Peyronie's Disease
- Study coordinator: Landon Trost, MD
- Email: email@mfp.clinic
- Phone: 801-655-0015
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.
Conditions: Peyronie Disease, collagenase clostridium histolyticum, curvature, Restorex, Xiaflex, traction, salvage