Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

Initia60 enrolled

Overview

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vasculogenic Erectile Dysfunction

Interventions

Shockwave systemDEVICE

Sham treatmentDEVICE

Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Good general health * Vasculogenic 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: * Psychogenic ED * Neurological pathology * Hormonal pathology * Past radical prostatectomy * 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 * Radiotherapy in pelvic region

Locations (1)

Meir Medical Center

Kfar Saba, Israel

Outcomes

Primary Outcomes

Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment

Time frame: 1, 3 and 6 months post treatment

Secondary Outcomes

Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment

Time frame: 1, 3 and 6 months post treatment

Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment

Time frame: 1, 3 and 6 months post treatment

Data from ClinicalTrials.gov

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