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

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

Recruiting
18 years and older
Male
Phase N/A

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Overview

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

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.

Study details
    Peyronie Disease
    Erectile Dysfunction

NCT06065436

Mayo Clinic

28 April 2025

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