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Enzyme

Surgery + Xiaflex + RestoreX for Peyronie's Disease (iSCRIP Trial)

Phase 4
Waitlist Available
Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men with PD
>18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

iSCRIP Trial Summary

This trial is comparing surgery and shots to see which is better for Peyronie's Disease.

Who is the study for?
Men over 18 with Peyronie's Disease (PD) who have a curvature of at least 30 degrees and can achieve an erection suitable for intercourse, with or without medication. Men who've had previous treatments with collagenase or surgery, or have moderate to severe penile calcification cannot participate.Check my eligibility
What is being tested?
This study compares the effectiveness of collagenase injections versus two types of surgery (Incision & Grafting and Penile Plication) in managing PD. It also examines the use of a RestoreX Penile Traction Device as part of treatment.See study design
What are the potential side effects?
Collagenase may cause swelling, pain at the injection site, and bruising. Surgery risks include infection, changes in penis sensation, erectile dysfunction, and scarring. The traction device might cause discomfort or skin irritation.

iSCRIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man diagnosed with Parkinson's disease.
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I am older than 18 years.

iSCRIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International Index of Erectile Function, Erectile Function Domain (IIEF) Scores
Overall satisfaction with treatment
Subjective reporting of changes in penile length post treatment
+2 more
Secondary outcome measures
Beck's Depression Inventory (BDI) Scores
Hospitalizations
International Index of Erectile Function (IIEF) Scores
+5 more

iSCRIP Trial Design

2Treatment groups
Active Control
Group I: Surgery+PTTActive Control3 Interventions
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 II: CCH+PTTActive Control2 Interventions
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Collagenase Clostridium Histolyticum (CCH) is a treatment for Peyronie's Disease that works by enzymatically breaking down the collagen in the fibrous plaques responsible for penile curvature. This mechanism is significant for patients because it offers a non-surgical option to reduce curvature and improve penile function, potentially leading to better outcomes and quality of life.

Find a Location

Who is running the clinical trial?

Charitable Union for the Research and Education of Peyronie's DiseaseLead Sponsor
3 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Peyronie's Disease
40 Patients Enrolled for Peyronie's Disease
Endo PharmaceuticalsIndustry Sponsor
133 Previous Clinical Trials
33,115 Total Patients Enrolled
12 Trials studying Peyronie's Disease
1,905 Patients Enrolled for Peyronie's Disease

Media Library

Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH) (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT04786106 — Phase 4
Peyronie's Disease Research Study Groups: Surgery+PTT, CCH+PTT
Peyronie's Disease Clinical Trial 2023: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH) Highlights & Side Effects. Trial Name: NCT04786106 — Phase 4
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH) (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786106 — Phase 4
~18 spots leftby Feb 2027
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