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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

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.