Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

Detailed Description
-----------------
ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option. The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy). LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.

Official Title
-----------------
Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency

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

Intervention / Treatment
-----------------
* Device: MoreNova


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his informed and signed written consent The patient is a male Between 40 to and including 55 years of age The patient has ED for longer than 1 year but less than 5 years. The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i IIEF-EF Domain score of 17-20 Evidence Based Criteria: Doppler Clinical Exam Exclusion Criteria: The patient is participating in another study that may interfere with the results or conclusions of this study History of radical prostatectomy or extensive pelvic surgery Past radiation therapy of the pelvic region within 12 months prior to enrollment Recovering from cancer within 12 months prior to enrollment Neurological disease which effects erectile function Psychiatric disease which effects erectile function The patient is taking blood thinners History of Diabetes Mellitus History of Coronary Artery Disease Evidence Based Criteria: Doppler Clinical Exam Severe erectile dysfunction with IIEF-EF domain score < 16

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Males with erectile dysfunction (ED)<br>Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device | Device: MoreNova<br>* Shockwave therapy delivered to the genital area with low dose shocks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cavernosal artery inflow | Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Baseline, treatment 6, 3-4 month follow up | 
| Change in peak systolic velocity | Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Baseline, treatment 6, 3-4 month follow up | 
| Change in diastolic velocity | Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second | Baseline, treatment 6, 3-4 month follow up | 
| Change in erection hardness | Measured using a self-reported erection hardness score (EHS) using a scale of 0 is penis does not change and 4 is penis is completely hard and fully rigid | Baseline, treatment 6, 1 month follow up, 3-4 month follow up |