120
Participants
Start Date
April 6, 2021
Primary Completion Date
May 24, 2024
Study Completion Date
May 24, 2024
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.
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.
Hôpital Rangueil, Toulouse
Centre d'Urologie du Polygone, Montpellier
Foch hospital, Suresnes
Hôpital Pasteur 2, Nice
Collaborators (1)
Dornier MedTech Systems
INDUSTRY
Hopital Foch
OTHER