NCT06065436 Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
| NCT ID | NCT06065436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Peyronie Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Tobias Kohler, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06065436 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Peyronie Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06065436 currently recruiting?
Yes, NCT06065436 is actively recruiting participants. Contact the research team at Anians.Wyatt@mayo.edu for enrollment information.
Where is the NCT06065436 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06065436 clinical trial?
NCT06065436 is sponsored by Mayo Clinic. The principal investigator is Tobias Kohler, MD at Mayo Clinic. The trial plans to enroll 60 participants.