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

Recruiting now · Not applicable

Conditions studied: Peyronie Disease, Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT06065436

Run by

Mayo Clinic

People needed

60

Starts

2024-01-19

Expected to finish

2027-01-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Minnesota — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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