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

NCT04786106 | Active Not Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: CUREPD101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie's Disease

Keywords

collagenase clostridium histolyticum; RestoreX; plication; incision and grafting; surgery

Outcome Measures

Primary Outcomes (5)

• Overall satisfaction with treatment

  Answer to SAPS question #1 (How satisfied are you with the effect of your treatment?) to determine overall satisfaction at all time points

  1 year

• Subjective reporting of erectile dysfunction post treatment

  Comparison of erectile dysfunction complication rates

  1 year

• Subjective reporting of changes in penile sensation post treatment

  Comparison of changes in penile sensation complication rates

  1 year

• Subjective reporting of changes in penile length post treatment

  Comparison of perceived changes in penile length complication rates

  1 year

• International Index of Erectile Function, Erectile Function Domain (IIEF) Scores

  Comparison of IIEF erectile function domain score (Q1-5, 15; min/max 1-30; higher is better)

  1 year

Secondary Outcomes (8)

• Peyronie's Disease Questionnaire (PDQ) Scores

  1 year

• International Index of Erectile Function (IIEF) Scores

  1 year

• Beck's Depression Inventory (BDI) Scores

  1 year

• Penile Curvature

  1 year

• Objective measurements of penile length post treatment (compared to pre-treatment)

  1 year

Study Arms (2)

CCH+PTT

ACTIVE COMPARATOR

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.

Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH); Device: RestoreX Penile Traction Device

Surgery+PTT

ACTIVE COMPARATOR

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.

Procedure: Penile Plication Surgery; Procedure: Incision and Grafting (I&G) Surgery; Device: RestoreX Penile Traction Device

Interventions

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH) 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.

Also known as: Xiaflex

CCH+PTT

Penile Plication Surgery 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.

Surgery+PTT

Incision and Grafting (I&G) Surgery 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.

Surgery+PTT

RestoreX Penile Traction Device 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.

CCH+PTT; Surgery+PTT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charitable Union for the Research and Education of Peyronie's Disease: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

The Male Fertility and Peyronie's Clinic

Orem, Utah, 84057, United States

Location

MeSH Terms

Conditions

Penile Induration; Surgical Wound

Interventions

Microbial Collagenase; Transplantation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The curvature and length assessments will be performed without knowledge as to pre-treatment measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: March 8, 2021
• Study Start: December 30, 2020
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

US (1)