RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease

Quick Facts

Study Start:2024-10-11
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06649539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men with Peyronie's Disease
  2. * Older than 18 years old
  3. * Curvature ≥30 degrees
  4. * Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
  5. * The patient exhibits a palpable plaque consistent with Peyronie's Disease
  6. * For partners, the only inclusion criteria is being willing to complete a questionnaire
  1. * Prior surgical treatment on the penis (other than circumcision)
  2. * Prior treatment with CCH injections
  3. * Any contraindications to CCH - as determined by the PI

Contacts and Locations

Study Contact

Landon Trost, MD
CONTACT
801-655-0015
email@mfp.clinic
Holli Burgon
CONTACT
801-691-4714
burgon.holli@menshealthstudies.com

Principal Investigator

Landon Trost, MD
PRINCIPAL_INVESTIGATOR
Charitable Union for the Research and Education of Peyronie's Disease

Study Locations (Sites)

Male Fertility and Peyronie's Clinic
Orem, Utah, 84057
United States

Collaborators and Investigators

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

  • Landon Trost, MD, PRINCIPAL_INVESTIGATOR, Charitable Union for the Research and Education of Peyronie's Disease

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11
Study Completion Date2029-10

Study Record Updates

Study Start Date2024-10-11
Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

  • collagenase clostridium histolyticum
  • curvature
  • Restorex
  • Xiaflex
  • traction
  • salvage

Additional Relevant MeSH Terms

  • Peyronie Disease