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Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Recruiting
Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Who can join
Ages 18 and older · Men
Full 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.About the study
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.
What is being tested
- Collagenase Clostridium Histolyticum (drug)
- Storz Duolith LiSWT (device)
Sponsor: Mayo Clinic · Participants: 60 · Started: Jan 19, 2024
Contact the study team
- Wyatt H Anians, CCRP · Phone: 507-538-6151
Official record on ClinicalTrials.gov — NCT06065436
Locations in the U.S.
| Minnesota | Mayo Clinic Minnesota, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.