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Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's

NCT04786106 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

  • Peyronie's Disease

Interventions

DRUG

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)

Men in this cohort would receive the full series of 8 Xiaflex injections: 2 injections separated by 1-3 days, repeated 3 additional times with 6 week breaks between treatments.

PROCEDURE

Penile Plication Surgery

Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures \<70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment.

PROCEDURE

Incision and Grafting (I&G) Surgery

Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures \<70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment.

DEVICE

RestoreX Penile Traction Device

RestoreX is a Class I PTT device developed by PathRight Medical, is registered with the FDA, and has randomized controlled data demonstrating efficacy when used for the treatment of PD.

Sponsors & Collaborators

  • Endo Pharmaceuticals

    collaborator INDUSTRY

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2027-02-15
Completion
2027-02-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786106 on ClinicalTrials.gov