Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction

N/ACompletedNCT02005731

Initia58 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vasculogenic Erectile Dysfunction

Interventions

Low intensity linear focused shockwave device ('Renova')DEVICE

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 (4)

Urologickaambulance

Brno, Czechia

Amber Clinic

Klaipėda, Lithuania

Men's Health Clinic, Amstelland Hospital

Amsterdam, Netherlands

Urology and Andrology Center, Red Crescent Hospital (RCH)

Ramallah, Palestinian Territories

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 SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment

Time frame: 1, 3 and 6 months post treatment

Responses to the GAQ (Global Assessment questions) Questions 1 and 2 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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