Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

Charitable Union for the Research and Education of Peyronie's Disease

Status and phase: Enrolling; Phase 4

Conditions: Peyronie Disease

Treatments: Drug: Collagenase Clostridium Histolyticum; Drug: Sildenafil; Device: RestoreX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06649539

CUREPD120

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Primary Cohort

Experimental group

Description:

Men would receive 4 series of CCH injections: * Administered on back-to-back days * 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 applied 2-4 full-time and 2-4 part-time days * Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min/day) 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. * Performed 9-12 months after the 4th series of injections. * The technique would incorporate more aggressive, in-office modeling. * Men would receive up to two additional series per this protocol.

Treatment:

Device: RestoreX

Drug: Sildenafil

Drug: Collagenase Clostridium Histolyticum