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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
Must not have
Prior intralesional injections or surgery for PD
Moderate or severe baseline ED based on IIEF-EF domain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had injections or surgery for Peyronie's disease.
Select...
I have moderate to severe erectile dysfunction.
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My plaque calcification is moderate to severe.
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I have severe pain in my penis.
Select...
My penis curves downward or downward to the side.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in erectile function
Change in penetrative sexual intercourse
Change in symptom bother
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,085 Total Patients Enrolled
Tobias Kohler, MDPrincipal InvestigatorMayo Clinic
~33 spots leftby Dec 2025
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