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

Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peyronie's Disease
• Intervention / Treatment: Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH); Device: RestoreX Penile Traction Device; Procedure: Penile Plication Surgery; Procedure: Incision and Grafting (I&G) Surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Xiaflex; 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.
Active Comparator: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peyronie's Disease Questionnaire (PDQ) Scores	Comparison of PDQ questionnaire scores; Subdomains - psychological and physical (Q1-6; min/max 0-24; lower is better), penile pain (Q7-9; min/max 0-30; lower is better), symptom bother (Q10-15; min/max 0-16; lower is better)	1 year
International Index of Erectile Function (IIEF) Scores	Comparison of IIEF questionnaire scores-all domains except erectile function (which is a primary endpoint); subdomains: orgasmic function (Q9-10; min/max 0-10; higher is better), sexual desire (Q11-12; min/max 2-10; higher is better), intercourse satisfaction (Q6-8; min/max 0-15; higher is better), overall satisfaction (Q13-14; min/max 2-10; higher is better)	1 year
Beck's Depression Inventory (BDI) Scores	Comparison of BDI questionnaire scores on depression. 21 items (min/max 0-63, lower is better)	1 year
Penile Curvature	Comparison of changes in penile curvature	1 year
Objective measurements of penile length post treatment (compared to pre-treatment)	Comparison of changes in penile length	1 year
Interventions required	Comparison of subsequent interventions required - surgery or CCH injections	1 year
Hospitalizations	Number of hospitalizations or ER visits resulting from treatment	1 year
Non-standardized questionnaire	Comparison of non-standardized questionnaire responses	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: surgery; collagenase clostridium histolyticum; RestoreX; plication; incision and grafting
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Penile Induration
• Other Study ID Numbers: CUREPD101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes