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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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.
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.
Centre d'Urologie du Polygone
Montpellier, France
Hôpital Pasteur 2
Nice, France
Foch hospital
Suresnes, France
Hôpital Rangueil
Toulouse, France
Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease
Average change in penile curvature based on the pictures taken by the patient (face and profil) at baseline and after the 6 week follow-up. The assessment will be performed by a blinded assessor at the end of the study
Time frame: 15 months
Assessment of the safety of ESWT on patients with PD: adverse events
Treatment related adverse events recorded at each visits.
Time frame: 3 months
Assessment of the effect of ESWT on penile pain
Patient complete at each visit a numeric rating scale of penile pain graduated from 0 (no pain) to 10 (worst pain) 0 means the patient has no pain and 10 for worst pain
Time frame: 3 months
Assessment of the effect of ESWT on sexual bother
Difference of the score of the International Index of Erectile Function (IIEF-5) reported by the patient at baseline and after 6 week follow-up. The score is calculated through 5 questions with answers ranging from 0 to 5. Between 26 and 30, the score indicates no erectile dysfunction. Between 17 and 25, it indicates mild dysfunction. Between 11 and 16, it indicates a moderate dysfunction and below 10 a complete or severe dysfunction.
Time frame: 3 months
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