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

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 6, 2021

Primary Completion Date

May 24, 2024

Study Completion Date

May 24, 2024

Conditions
Peyronie DiseasePenile Diseases
Interventions
DEVICE

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.

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.

Trial Locations (4)

31059

Hôpital Rangueil, Toulouse

34000

Centre d'Urologie du Polygone, Montpellier

92151

Foch hospital, Suresnes

06000

Hôpital Pasteur 2, Nice

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dornier MedTech Systems

INDUSTRY

lead

Hopital Foch

OTHER