Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
- Conditions
- Peyronie's Disease
- Interventions
- Procedure: Penile Plication SurgeryDevice: RestoreX Penile Traction DeviceProcedure: Incision and Grafting (I&G) Surgery
- Registration Number
- NCT04786106
- Lead Sponsor
- Charitable Union for the Research and Education of Peyronie's Disease
- Brief Summary
The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.
- Detailed Description
After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 40
- Men with PD
- >18 years old
- Curvature ≥30 degrees
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
- Prior treatment with CCH or surgery
- Moderate (shadowing) or severe (>1 cm) penile calcification
- Any contraindications to CCH, PTT, or surgery - as determined by the PI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CCH+PTT RestoreX Penile Traction Device Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit. Surgery+PTT Penile Plication Surgery Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit. Surgery+PTT Incision and Grafting (I&G) Surgery Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit. Surgery+PTT RestoreX Penile Traction Device Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit. CCH+PTT Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH) Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit.
- Primary Outcome Measures
Name Time Method Subjective reporting of erectile dysfunction post treatment 1 year Comparison of erectile dysfunction complication rates
Overall satisfaction with treatment 1 year Answer to SAPS question #1 (How satisfied are you with the effect of your treatment?) to determine overall satisfaction at all time points
Subjective reporting of changes in penile length post treatment 1 year Comparison of perceived changes in penile length complication rates
International Index of Erectile Function, Erectile Function Domain (IIEF) Scores 1 year Comparison of IIEF erectile function domain score (Q1-5, 15; min/max 1-30; higher is better)
Subjective reporting of changes in penile sensation post treatment 1 year Comparison of changes in penile sensation complication rates
- Secondary Outcome Measures
Name Time Method Peyronie's Disease Questionnaire (PDQ) Scores 1 year Comparison of PDQ questionnaire scores; Subdomains - psychological and physical (Q1-6; min/max 0-24; lower is better), penile pain (Q7-9; min/max 0-30; lower is better), symptom bother (Q10-15; min/max 0-16; lower is better)
International Index of Erectile Function (IIEF) Scores 1 year Comparison of IIEF questionnaire scores-all domains except erectile function (which is a primary endpoint); subdomains: orgasmic function (Q9-10; min/max 0-10; higher is better), sexual desire (Q11-12; min/max 2-10; higher is better), intercourse satisfaction (Q6-8; min/max 0-15; higher is better), overall satisfaction (Q13-14; min/max 2-10; higher is better)
Beck's Depression Inventory (BDI) Scores 1 year Comparison of BDI questionnaire scores on depression. 21 items (min/max 0-63, lower is better)
Penile Curvature 1 year Comparison of changes in penile curvature
Objective measurements of penile length post treatment (compared to pre-treatment) 1 year Comparison of changes in penile length
Interventions required 1 year Comparison of subsequent interventions required - surgery or CCH injections
Hospitalizations 1 year Number of hospitalizations or ER visits resulting from treatment
Non-standardized questionnaire 1 year Comparison of non-standardized questionnaire responses
Trial Locations
- Locations (1)
The Male Fertility and Peyronie's Clinic
🇺🇸Orem, Utah, United States