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

Primary Purpose

Peyronie's Disease

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)
Penile Plication Surgery
Incision and Grafting (I&G) Surgery
RestoreX Penile Traction Device
Sponsored by
Charitable Union for the Research and Education of Peyronie's Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peyronie's Disease focused on measuring collagenase clostridium histolyticum, RestoreX, plication, incision and grafting, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Male Fertility and Peyronie's Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CCH+PTT

Surgery+PTT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Subjective reporting of erectile dysfunction post treatment
Comparison of erectile dysfunction complication rates
Subjective reporting of changes in penile sensation post treatment
Comparison of changes in penile sensation complication rates
Subjective reporting of changes in penile length post treatment
Comparison of perceived changes in penile length complication rates
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)

Secondary Outcome Measures

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)
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)
Beck's Depression Inventory (BDI) Scores
Comparison of BDI questionnaire scores on depression. 21 items (min/max 0-63, lower is better)
Penile Curvature
Comparison of changes in penile curvature
Objective measurements of penile length post treatment (compared to pre-treatment)
Comparison of changes in penile length
Interventions required
Comparison of subsequent interventions required - surgery or CCH injections
Hospitalizations
Number of hospitalizations or ER visits resulting from treatment
Non-standardized questionnaire
Comparison of non-standardized questionnaire responses

Full Information

First Posted
February 5, 2021
Last Updated
September 11, 2023
Sponsor
Charitable Union for the Research and Education of Peyronie's Disease
Collaborators
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04786106
Brief Title
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Acronym
iSCRIP
Official Title
Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
February 15, 2027 (Anticipated)
Study Completion Date
February 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charitable Union for the Research and Education of Peyronie's Disease
Collaborators
Endo Pharmaceuticals

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie's Disease
Keywords
collagenase clostridium histolyticum, RestoreX, plication, incision and grafting, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The curvature and length assessments will be performed without knowledge as to pre-treatment measurements.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCH+PTT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgery+PTT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)
Other Intervention Name(s)
Xiaflex
Intervention Description
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
Procedure
Intervention Name(s)
Penile Plication Surgery
Intervention Description
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
Intervention Name(s)
Incision and Grafting (I&G) Surgery
Intervention Description
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
Device
Intervention Name(s)
RestoreX Penile Traction Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall satisfaction with treatment
Description
Answer to SAPS question #1 (How satisfied are you with the effect of your treatment?) to determine overall satisfaction at all time points
Time Frame
1 year
Title
Subjective reporting of erectile dysfunction post treatment
Description
Comparison of erectile dysfunction complication rates
Time Frame
1 year
Title
Subjective reporting of changes in penile sensation post treatment
Description
Comparison of changes in penile sensation complication rates
Time Frame
1 year
Title
Subjective reporting of changes in penile length post treatment
Description
Comparison of perceived changes in penile length complication rates
Time Frame
1 year
Title
International Index of Erectile Function, Erectile Function Domain (IIEF) Scores
Description
Comparison of IIEF erectile function domain score (Q1-5, 15; min/max 1-30; higher is better)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Peyronie's Disease Questionnaire (PDQ) Scores
Description
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)
Time Frame
1 year
Title
International Index of Erectile Function (IIEF) Scores
Description
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)
Time Frame
1 year
Title
Beck's Depression Inventory (BDI) Scores
Description
Comparison of BDI questionnaire scores on depression. 21 items (min/max 0-63, lower is better)
Time Frame
1 year
Title
Penile Curvature
Description
Comparison of changes in penile curvature
Time Frame
1 year
Title
Objective measurements of penile length post treatment (compared to pre-treatment)
Description
Comparison of changes in penile length
Time Frame
1 year
Title
Interventions required
Description
Comparison of subsequent interventions required - surgery or CCH injections
Time Frame
1 year
Title
Hospitalizations
Description
Number of hospitalizations or ER visits resulting from treatment
Time Frame
1 year
Title
Non-standardized questionnaire
Description
Comparison of non-standardized questionnaire responses
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The Male Fertility and Peyronie's Clinic
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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