Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease
Charitable Union for the Research and Education of Peyronie's Disease
Summary
Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH. The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data. Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2. The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.
Description
The current study would prospectively follow 40 men through the following treatment protocol: * Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13 * Medication administered on back-to-back days * Total of 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising * Sildenafil 25 mg nightly beginning treatment day 2 until 6…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugCollagenase Clostridium Histolyticum
4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series. Total of 0.9 mg administered with each series, diluted to 0.8 mL
- DeviceRestoreX
Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.
- DrugSildenafil
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Location
- Male Fertility and Peyronie's ClinicOrem, Utah