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

NCT ID: NCT04821115

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2024-05-24

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.

Conditions

Peyronie Disease; Penile Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low intensity choc waves therapy (Experimental group)

The patients will use the device with a real applicator.

Group Type: EXPERIMENTAL

Low intensity choc waves therapy (active applicator)

Intervention Type: DEVICE

At each of the 4 sessions, 4000 shockwaves will be delivered at level 8 (EFD = 0.133 mJ/mm2), over a period of 15 to 20 minutes. The probe will be applied directly to the plaque, on the flaccid penis. The device will stop automatically after the 4000 shock waves.

Sham group

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

Group Type: SHAM_COMPARATOR

Sham (sham applicator)

Intervention Type: DEVICE

At each of the 4 sessions, a sham applicator will be used. The sham applicator has an internal foam pad that disperses the shockwave energy, but is not visible from the outside. The sham applicator will look, feel and sound the same as the active, but no measurable energy is emitted.

Interventions

Low intensity choc waves therapy (active applicator)

At each of the 4 sessions, 4000 shockwaves will be delivered at level 8 (EFD = 0.133 mJ/mm2), over a period of 15 to 20 minutes. The probe will be applied directly to the plaque, on the flaccid penis. The device will stop automatically after the 4000 shock waves.

Intervention Type: DEVICE

Sham (sham applicator)

At each of the 4 sessions, a sham applicator will be used. The sham applicator has an internal foam pad that disperses the shockwave energy, but is not visible from the outside. The sham applicator will look, feel and sound the same as the active, but no measurable energy is emitted.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dornier MedTech Systems

INDUSTRY

Sponsor Role: collaborator

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry LEBRET, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

Centre d'Urologie du Polygone

Montpellier, , France

Hôpital Pasteur 2

Nice, , France

Foch hospital

Suresnes, , France

Hôpital Rangueil

Toulouse, , France

Countries

France

Other Identifiers

2019_0075

Identifier Type: -

Identifier Source: org_study_id