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Recruiting NCT06065436

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

Conditions: Peyronie Disease, Erectile Dysfunction

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Mayo Clinic

Location: Mayo Clinic Minnesota Rochester Minnesota

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06065436). StuddyBuddy aggregates publicly available trial information.