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

NCT ID: NCT04786106

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2027-02-15

Brief 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.

Detailed Description

After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.

Conditions

Peyronie's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CCH+PTT

Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit.

Group Type: ACTIVE_COMPARATOR

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)

Intervention Type: DRUG

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.

RestoreX Penile Traction Device

Intervention Type: 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.

Surgery+PTT

Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit.

Group Type: ACTIVE_COMPARATOR

Penile Plication Surgery

Intervention Type: PROCEDURE

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.

Incision and Grafting (I&G) Surgery

Intervention Type: PROCEDURE

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.

RestoreX Penile Traction Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Xiaflex

Eligibility Criteria

Inclusion Criteria

• Men with PD
• >18 years old
• Curvature ≥30 degrees
• Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors

Exclusion Criteria

• Prior treatment with CCH or surgery
• Moderate (shadowing) or severe (>1 cm) penile calcification
• Any contraindications to CCH, PTT, or surgery - as determined by the PI

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Male Fertility and Peyronie's Clinic

Orem, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CUREPD101

Identifier Type: -

Identifier Source: org_study_id