Radial Shockwave Therapy for Erectile Dysfunction

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 19, 2018

Primary Completion Date

March 9, 2021

Study Completion Date

March 9, 2021

Conditions
Erectile Dysfunction
Interventions
DEVICE

Radial wave therapy

6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.

DEVICE

Placebo therapy

"There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the real therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation."

Trial Locations (1)

11022

Boston Medical Group Colombia, Bogotá

Sponsors
All Listed Sponsors
lead

Boston Medical Group

INDUSTRY

NCT03596047 - Radial Shockwave Therapy for Erectile Dysfunction | Biotech Hunter | Biotech Hunter