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NCT06065436NARecruiting

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

Mayo Clinic

Start Date

1/19/2024

Completion Date

1/1/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Collagenase Clostridium Histolyticum

DEVICE

Storz Duolith LiSWT

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Conditions

Peyronie DiseaseErectile Dysfunction

Locations

Mayo Clinic Minnesota

Rochester, Minnesota 55905

United States