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

Last updated: April 21, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peyronie's Disease

Infertility

Impotence

Treatment

Storz Duolith LiSWT

Collagenase Clostridium Histolyticum

Clinical Study ID

NCT06065436
23-002478
  • Ages > 18
  • Male

Study 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

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 duringobjective curvature assessment

  • Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) asdetermined by penile duplex Doppler ultrasound (PDDU)

  • "Stable PD symptoms' defined as PD symptom duration > 6-months or stable symptoms > 3-months

Exclusion

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 curvatureassessment.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Storz Duolith LiSWT
Phase:
Study Start date:
January 19, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Mayo Clinic Minnesota

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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