Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

Initia2 enrolled

Overview

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vasculogenic Erectile Dysfunction

Interventions

Low Intensity Shockwave by RenovaDEVICE

Sham treatmentDEVICE

Sham treatment that looks, sounds and feels like the real LISW treatment.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Good general health * Vascular ED for at least 6 months * International Index of Erectile Function 6 (IIEF-EF) between 11 to 25 * Positive response to PDE5-I (able to penetrate on demand=Responders) * Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage = Non-responders) * Stable heterosexual relationship for more than 3 months Exclusion Criteria: * Hormonal, neurological or psychological pathology * Past radical prostatectomy or extensive pelvic surgery * Recovering from cancer during last 5 years * Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities * Clinically significant chronic hematological disease * Anti-androgens, oral or injectable androgens * Past radiotherapy treatment of the pelvic region * International normalized ratio (INR) \> 3 for patients using blood thinners (such as Coumadin)

Locations (1)

The Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment