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

Peyronie's Disease Clinical Trial

— iSCRIP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04786106
• Other study ID #: CUREPD101
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 30, 2020
• Est. completion date: February 15, 2027

Study information

• Verified date: September 2023
• Source: Charitable Union for the Research and Education of Peyronie's Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 15, 2027
• Est. primary completion date: February 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Male Fertility and Peyronie's Clinic	Orem	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Charitable Union for the Research and Education of Peyronie's Disease	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Subjective reporting of erectile dysfunction post treatment	Comparison of erectile dysfunction complication rates	1 year
Primary	Subjective reporting of changes in penile sensation post treatment	Comparison of changes in penile sensation complication rates	1 year
Primary	Subjective reporting of changes in penile length post treatment	Comparison of perceived changes in penile length complication rates	1 year
Primary	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	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
Secondary	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
Secondary	Beck's Depression Inventory (BDI) Scores	Comparison of BDI questionnaire scores on depression. 21 items (min/max 0-63, lower is better)	1 year
Secondary	Penile Curvature	Comparison of changes in penile curvature	1 year
Secondary	Objective measurements of penile length post treatment (compared to pre-treatment)	Comparison of changes in penile length	1 year
Secondary	Interventions required	Comparison of subsequent interventions required - surgery or CCH injections	1 year
Secondary	Hospitalizations	Number of hospitalizations or ER visits resulting from treatment	1 year
Secondary	Non-standardized questionnaire	Comparison of non-standardized questionnaire responses	1 year