RecruitingPhase 2NCT06161506

Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

41 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using surface electrical stimulation — small electrical pulses applied to the skin — can help men who experience urinary leakage (incontinence) after prostate cancer surgery. The device stimulates the muscles that control urination to help them recover. **You may be eligible if...** - You are a man who had prostate removal surgery (radical prostatectomy) for prostate cancer - You are experiencing urinary incontinence (leaking urine) after the surgery - You are at least 18 years old **You may NOT be eligible if...** - You have a cardiac pacemaker or other implanted electronic device - You have a skin condition or open wounds in the treatment area - You have a neurological condition affecting bladder control - Your incontinence is caused by something other than the surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElidah Device

The Elidah device is a modified version of the FDA approved ELITONE device cleared for use in the treatment of female stress urinary incontinence. For the current study, only minor modifications have been implemented with respect to the shape of the electrode component, providing a contour better suited to fit the male anatomy.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06161506


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