NCT04821115CompletedNot Applicable
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Foch
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease
Study Overview
Brief Summary
Investigation of the effect of Low-intensity extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) via a single blind, sham-controlled, randomized clinical trial. Investigators will not be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old male,
- •Untreated Peyronie's disease (excepted oral therapy) (wash out: at least 1 month),
- •Single axis penile curvature in erection at 20 - 90 degrees at baseline,
- •Dorsal or lateral penile plaque,
- •Able and willing to perform ESWT self-treatment under supervision,
- •Able to understand and complete patient questionnaires,
- •Having sign an informed consent form prior to any study specific procedure,
- •Being covered by a national health insurance
Exclusion Criteria
- •Congenital penile deformity,
- •Hourglass deformity,
- •Circumferential plaque,
- •Septal or ventral plaque,
- •Plaque that cannot be palpated during clinical examination,
- •Previous intralesional injection for Peyronie's Disease,
- •Severe erectile dysfunction (EHS < 3),
- •Current penile, malignancy,
- •Previous penile surgery except for circumcision or condyloma removal,
- •Previous pelvic radiation therapy,
- •Anti-coagulant medication, except acetylsalicylic acid up to 100mg daily,
- •Previous low-intensity focused shockwave therapy on penis,
- •Any other condition that would prevent the patient from completing the study, as judged by the principal investigator,
- •Being deprived of liberty or under guardianship.
Outcomes
Primary Outcomes
Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease
Time Frame: 15 months
Average change in penile curvature based on the pictures taken by the patient (face and profil) at baseline and after the 6 week follow-up. The assessment will be performed by a blinded assessor at the end of the study
Secondary Outcomes
- Assessment of the safety of ESWT on patients with PD: adverse events(3 months)
- Assessment of the effect of ESWT on penile pain(3 months)
- Assessment of the effect of ESWT on sexual bother(3 months)
Investigators
Study Sites (8)
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