Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ • Diagnosed with PD
• Palpable penile plaque
• Dorsal, lateral, or dorsolateral penile curvature
• Penile curvature \> 30 degrees and \< 90 degrees as measured using goniometer during objective curvature assessment
• Non-calcified plaque or grade 1 calcification (stippling, no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
• Stable PD symptoms' defined as PD symptom duration \> 6-months or stable symptoms \> 3-months
Locations
United States
Minnesota
Mayo Clinic Minnesota
RECRUITING
Rochester
Contact Information
Primary
Wyatt H Anians, CCRP
Anians.Wyatt@mayo.edu
507-538-6151
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
Active_comparator: Collagenase Clostridium Histolyticum
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic