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

Launched by MAYO CLINIC · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for Peyronie's Disease, which causes a curve in the penis that can lead to discomfort and difficulties during erections. The researchers want to find out if combining low-intensity shockwave therapy with an injectable medication called Xiaflex can help improve the curvature more effectively than using Xiaflex alone. The trial is currently looking for male participants aged between 65 and 74 who have been diagnosed with Peyronie's Disease and have a noticeable curvature of the penis between 30 and 90 degrees.

To be eligible for this study, participants must have stable symptoms for at least six months and should not have had previous surgeries or injections for Peyronie’s Disease. They also need to have certain characteristics in their penile plaque, as determined by an ultrasound test. If you join the trial, you can expect to receive the combined treatment and be monitored for any changes in your condition. This trial aims to offer new hope for men dealing with this challenging condition.

Gender

MALE

Eligibility criteria

• • Inclusion Criteria
• • • 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
• Exclusion Criteria:
• • Prior intralesional injections or surgery for PD.
• • Severe baseline penile pain.
• • Moderate or severe baseline ED based on IIEF-EF domain.
• • History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
• • Ventral (downward) or ventrolateral penile curvature.
• • Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
• • Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.