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

Hopital Foch

Status: Completed

Conditions: Penile Diseases; Peyronie Disease

Treatments: Device: Sham (sham applicator); Device: Low intensity choc waves therapy (active applicator)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04821115

2019_0075

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Low intensity choc waves therapy (Experimental group)

Experimental group

Description:

The patients will use the device with a real applicator.

Treatment:

Device: Low intensity choc waves therapy (active applicator)

Sham group

Sham Comparator group

Description:

The patients will use the device with a sham applicator. Instead of a focusing lens, the applicator will have an internal foam piece that will dissipate the energy of the shockwave. Hence, the sham applicator will look, feel and sound the same as the active, but no measurable energy is emitted

Treatment:

Device: Sham (sham applicator)