Using shockwave therapy with Xiaflex to treat Peyronie's disease
Official title: Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Run by Mayo Clinic · NCT06065436 · Data updated 2026-11-12
This study is testing if combining shockwave therapy with a medication called Xiaflex can help men with Peyronie's disease improve their penile curvature better than standard treatment alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 19, 2024 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT06065436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men diagnosed with Peyronie's disease who have a palpable penile plaque and curvature between 30 and 90 degrees.
✕Probably not a fit
Patients with severe erectile dysfunction, significant penile pain, or those who have previously undergone treatment for Peyronie's disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research aims to evaluate the effectiveness of low-intensity shockwave therapy (LiSWT) combined with collagenase Clostridium histolyticum (Xiaflex) in improving penile curvature in patients diagnosed with Peyronie's disease. Participants will undergo treatment to assess whether this combined approach leads to better outcomes compared to standard treatment alone. The study will focus on patients with specific curvature measurements and stable symptoms, ensuring a targeted approach to treatment. The methodology includes objective curvature assessments using a goniometer and penile duplex Doppler ultrasound to evaluate plaque characteristics.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the curvature of the penis for patients suffering from Peyronie's disease.
How similar studies have gone: While the combination of LiSWT and Xiaflex is a novel approach, similar studies have shown promise in using shockwave therapy for erectile dysfunction and Peyronie's disease.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Mayo Clinic Minnesota
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Tobias Kohler, MD — Mayo Clinic
- Study coordinator: Carter Day
- Email: Day.Carter@mayo.edu
- Phone: 507-422-5076
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.