Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction

NACompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

May 22, 2019

Study Completion Date

May 28, 2019

Conditions
Vasculogenic Erectile Dysfunction
Interventions
DEVICE

Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.

"This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. The patients are randomized in a 1:1 ratio into two active treatment groups.~Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).~Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)~."

Trial Locations (1)

33136

University of Miami, Miami

All Listed Sponsors
collaborator

DIREX SYSTEMS CORPORATION

INDUSTRY

lead

University of Miami

OTHER

NCT03067987 - Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction | Biotech Hunter | Biotech Hunter