Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease (NCT04821115) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
France120 participantsStarted 2021-04-06
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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.
What they're measuring
1
Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease