What side effects are associated with this type of intervention?

The most common treatment for Peyronie's Disease, Collagenase Clostridium Histolyticum (CCH) injections, is associated with several side effects. These include localized pain, swelling, bruising, and hematoma at the injection site. Some patients may also experience penile pain, itching, and tenderness. In rare cases, more severe complications such as penile fracture or corporal rupture can occur. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Collagenase Clostridium Histolyticum (CCH) is an FDA-approved treatment for Peyronie's Disease. Marketed under the brand name Xiaflex, CCH works by enzymatically breaking down the collagen buildup that causes penile curvature. This treatment involves a series of injections directly into the penile plaque, which helps to reduce curvature and improve symptoms. Xiaflex is currently the only FDA-approved medication specifically targeting the enzymatic breakdown of collagen in Peyronie's Disease.

What other types of research exist?

Promising novel alternatives to Collagenase Clostridium Histolyticum for Peyronie's Disease include surgical interventions and investigational therapies such as the use of Restorex traction therapy. Surgery remains a viable option for severe cases, offering more immediate correction of penile curvature. Additionally, Restorex, a penile traction therapy device, has shown potential in clinical studies to improve penile length and curvature without the need for invasive procedures.

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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

Must not have

Prior treatment with CCH or surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares enzyme injections with a stretching device to surgery with a stretching device for men with Peyronie's Disease. The enzyme helps dissolve scar tissue, while surgery corrects curvature. Both methods use a stretching device to help reshape and maintain the penis.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man diagnosed with Parkinson's disease.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had previous treatment with CCH or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Beck's Depression Inventory (BDI) Scores

Hospitalizations

International Index of Erectile Function (IIEF) Scores

+5 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 3Eligibility criteria met

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.