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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

Conditions
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Vasculogenic Erectile Dysfunction

Intervention / Treatment
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* Device: Shockwave system
* Device: Sham treatment


Participation Criteria
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Eligibility Criteria
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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

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwaves<br>4 weekly sessions of low-intensity shockwave therapy | Device: Shockwave system<br> <br> * Other names: Renova;|
| Sham Comparator: Control Group<br> | Device: Sham treatment<br>* Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.<br>|

What is the study measuring?
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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 1, 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 OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment |  | 1, 3 and 6 months post treatment | 
| Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment |  | 1, 3 and 6 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction