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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova

Conditions
-----------------
Vasculogenic Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: Low Intensity Shockwave by Renova
* Device: Sham treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Intensity Shockwave treatment<br>4 weekly sessions of Low Intensity Shockwave treatment. | Device: Low Intensity Shockwave by Renova<br> <br> |
| Sham Comparator: Control group<br> | Device: Sham treatment<br>* Sham treatment that looks, sounds and feels like the real LISW treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment |  | 1, 3 and 6 months post treatment | 
| Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment |  | 1, 3 and 6 months post treatment | 
| Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment |  | 1, 3 and 6 months post treatment | 
| Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment |  | 1, 3 and 6 months post treatment | 
| Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment |  | 0 and 6 months post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Extracorporeal shockwave, Low intensity shockwaves