NCT04821115

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-06
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2021-03-29
• Last updated: 2024-07-31

Locations

4 sites across 1 country: France