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Enzyme

Shockwave Therapy + Xiaflex for Peyronie's Disease

N/A

Recruiting

Led By Tobias Kohler, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with PD

Palpable penile plaque

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial tests if shockwave therapy combined with Xiaflex can reduce penile curvature, a common issue for men.

Who is the study for?

Men with Peyronie's Disease (PD) who have a significant bend in their penis (30-90 degrees), can feel the plaque causing the curve, and whose symptoms have been stable for at least 3 months. They shouldn't have had previous treatments for PD, severe pain or erectile dysfunction, certain types of penile curvature, or heavy plaque calcification.Check my eligibility

What is being tested?

The trial is testing if combining low-intensity shockwave therapy with Xiaflex injections improves straightening of the penis better than previous treatments alone. Participants will receive both therapies to see if there's greater improvement in penile curvature.See study design

What are the potential side effects?

Xiaflex may cause swelling, pain at the injection site, bruising, bleeding under the skin and sometimes an allergic reaction. Shockwave therapy could lead to mild discomfort during treatment.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Parkinson's disease.

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I can feel a lump in my penis.

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My penis curves to the side or upwards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Erectile Function Domain (IIEF-EF)

Change in erectile function

Change in penetrative sexual intercourse

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Collagenase Clostridium Histolyticum with Low Intensity Shockwave TherapyExperimental Treatment2 Interventions

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).

Group II: Collagenase Clostridium HistolyticumActive Control1 Intervention

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Collagenase Clostridium Histolyticum

2013

Completed Phase 3

~1010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,428 Total Patients Enrolled

2 Trials studying Peyronie's Disease

12 Patients Enrolled for Peyronie's Disease

Tobias Kohler, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

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

Are individuals still able to join this investigative study?

"This clinical trial, initially posted on November 1st 2023, is not presently seeking participants. However, there are 70 other trials that can be found currently recruiting patients."

Answered by AI