Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

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.

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.