Using shockwave therapy with Xiaflex to treat Peyronie's disease
Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06065436 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with Peyronie's disease who have a palpable penile plaque and curvature between 30 and 90 degrees.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Tobias Kohler, MD — Mayo Clinic
- Study coordinator: Wyatt H Anians, CCRP
- Email: Anians.Wyatt@mayo.edu
- Phone: 507-538-6151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.