delayed dose collagenase clostridium histolyticum (cch) protocol for men with peyronie's disease

Conditions: Peyronie 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.

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 weeks after final injection of the final series. * 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 series. * note that men may stop sooner if they are satisfied before completing the 4 series. * if the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * this would be performed 9-12 months after the 4th series of injections. * the technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial. * the men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total. at the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol. assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of cch injections, and 1 year after completion of the final series of cch injections.

Eligibility 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

Keywords: collagenase clostridium histolyticum curvature restorex xiaflex traction salvage