RecruitingNot ApplicableNCT06065436

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial


Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Collagenase Clostridium Histolyticum and a medical device called Storz Duolith LiSWT for people with erectile dysfunction and peyronie disease. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCollagenase Clostridium Histolyticum

Total of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart.

DEVICEStorz Duolith LiSWT

Single low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks/minute and using a power setting of 0.09 mJ/mm2. These treatments will occur four separate times, before each of the four separate CCH injection series.


Locations(1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

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NCT06065436


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