Actively Recruiting
Impact of Concurrent Low Intensity Shockwave Therapy on Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Led by Mayo Clinic · Updated on 2026-01-07
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Peyronie's Disease and erectile dysfunction to find out if combining low-intensity shockwave therapy (LiSWT) with Xiaflex (Collagenase Clostridium Histolyticum) injections improves the curvature of the penis better than Xiaflex injections alone. The trial aims to compare these treatments in men with stable symptoms and specific curvature measurements. This randomized study is sponsored by Mayo Clinic and focuses on clinical outcomes related to symptom bother, sexual intercourse ability, and erectile function. Participants will be randomly assigned to one of two groups. One group will receive eight Xiaflex injections divided into four series, with two injections each, spaced 1 to 7 days apart, combined with four sessions of low-intensity shockwave therapy given before each injection series. The other group will receive the Xiaflex injections alone as per standard care without shockwave therapy. The shockwave therapy involves delivering 1,500 shocks at a set rate and power using a specialized device. During the study, participants will be evaluated at the start and after six weeks for changes in symptom bother, ability to have penetrative sexual intercourse, need for surgical straightening, and erectile function measured by the International Index of Erectile Function (IIEF-EF). Researchers will monitor responses to treatment using physical assessments and questionnaires. The total duration of participation covers the injection series and follow-up assessments to track improvements and safety.
CONDITIONS
Brief Title
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Peyronie's Disease
- Palpable penile plaque
- Dorsal, lateral, or dorsolateral penile curvature
- Penile curvature greater than 30 degrees and less than 90 degrees as measured by goniometer
- Non-calcified plaque or grade 1 calcification without shadowing as determined by penile duplex Doppler ultrasound
- Stable Peyronie's Disease symptoms defined as symptom duration more than 6 months or stable symptoms for more than 3 months
You will not qualify if you...
- Prior intralesional injections or surgery for Peyronie's Disease
- Severe baseline penile pain
- Moderate or severe baseline erectile dysfunction based on IIEF-EF domain
- History of low intensity shockwave therapy for sexual dysfunction
- Ventral or ventrolateral penile curvature
- Moderate or severe plaque calcification (grade 2 or 3) as determined by penile duplex Doppler ultrasound
- Inability to achieve satisfactory erection rigidity at baseline curvature assessment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 weeks
Participants receive intralesional injections of Collagenase Clostridium Histolyticum administered as four series, each consisting of two injections 1 to 7 days apart. Participants in the experimental group also receive low intensity shockwave therapy before each injection series.
4 injection series with 2 injections each, plus 4 low intensity shockwave therapy sessions for the experimental group
Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
W
Wyatt H Anians, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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