Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136288
• Other study ID #: 18-001246
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• MoreNova
Shockwave therapy delivered to the genital area with low dose shocks

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in diastolic velocity	Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second	Baseline, treatment 6, 3-4 month follow up
Primary	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

External Links

•   Mayo Clinic Clinical Trials