Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT04136288|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Device: MoreNova||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||December 4, 2020|
Experimental: Males with erectile dysfunction (ED)
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
Shockwave therapy delivered to the genital area with low dose shocks
- Change in cavernosal artery inflow [ Time Frame: Baseline, treatment 6, 3-4 month follow up ]Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
- Change in peak systolic velocity [ Time Frame: Baseline, treatment 6, 3-4 month follow up ]Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
- Change in diastolic velocity [ Time Frame: Baseline, treatment 6, 3-4 month follow up ]Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
- Change in erection hardness [ Time Frame: Baseline, treatment 6, 1 month follow up, 3-4 month follow up ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136288
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Gregory Broderick, MD||Mayo Clinic|