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

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.

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.