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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.
Select...
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.

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
34,956 Total Patients Enrolled
12 Trials studying Peyronie's Disease
2,876 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ambition of this experiment?

"Over the course of 12 months, this experiment will measure changes in penile length. Secondary objectives include monitoring shifts in curvature, hospital visits due to treatment, and responses from a non-standardized questionnaire."

Answered by AI

Is recruitment still available for this research endeavor?

"Unfortunately, this clinical trial has already reached its participant capacity and is no longer recruiting. It was first posted on December 30th 2020 before being last updated on March 24th 2022. Nevertheless, there are presently 8 studies actively seeking patients with peyronie's disease and 6 trials for Surgery+PTT that are still accepting participants."

Answered by AI

What are the primary applications for Surgery+PTT?

"Surgery and physical therapy are commonly used to address palpable cord. This same treatment regimen may be beneficial for patients suffering from skin ulcers, penile deformity at an angle of 30 degrees or greater, as well as peyronie's disease."

Answered by AI

Could you provide a synopsis of any analogous trials focused on Surgery+PTT?

"Currently, there are six clinical trials conducted to research Surgery+PTT. One of these studies is in its third phase. Most of the related investigations occur in Orem, Utah; however, 11 other sites across the United States have joined this effort as well."

Answered by AI

How many participants are actively engaged in this research endeavor?

"This clinical trial is no longer recruiting participants, with the initially posting dating back to December 30th 2020 and its last update occurring on March 24th 2022. However, those looking for alternative studies can find 8 opportunities related to peyronie's disease and 6 trials that involve Surgery+PTT currently accepting new patients."

Answered by AI

Has Surgery+PTT been certified by the Food and Drug Administration?

"The safety of Surgery+PTT was rated a 3 on our scale due to the advanced stage of the clinical trial, indicating that this procedure has been approved."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
2020. "Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786106.
All > Surgery
~18 spots leftby Feb 2027
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