This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile dysfunction of at least 6 months duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries 2 device.
This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with an open-label extension. The study will include 4 sites and multiple investigators. A total of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors will be enrolled. The trial comprises two arms to achieve equal characteristics, where patients are randomly assigned to active treatment or sham treatment. All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2. Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and perfusion improvements to occur. The subjects' duration of participation will be a total of 34 weeks Subjects will also be asked to maintain their current level of sexual activity while participating in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
San Diego Sexual Medicine
San Diego, California, United States
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States
Manhattan Medical Research
New York, New York, United States
International Inventory of Erectile Function ("IIEF")
validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
Time frame: primary outcome at 3 month follow-up visit
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