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

Recruiting now · Phase 2

Conditions studied: Urinary Urge Incontinence, Stress Urinary Incontinence, Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT06161506

Run by

National Cancer Institute (NCI)

People needed

41

Starts

2024-02-15

Expected to finish

2028-03-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Change of therapy for prostate cancer planned during the study intervention.
• History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence.
• Active urinary tract infection (UTI) at screening or history of recurrent urinary tract infections (>= 4 UTIs within the 12 months prior to the study treatment initiation).
• History of complete denervation of the pelvic floor.
• Severe obesity (body mass index [BMI] >35).
• Pelvic pain/painful bladder syndrome.
• Metal implant in the abdominal or pelvic area.
• History of chronic cough with ongoing symptoms
• An implanted cardiac device, history of untreated cardiac arrhythmia, or history of other heart problems.
• History of epilepsy.
• History of underlying neurologic/neuromuscular disorder that could contribute to urinary incontinence.
• Change in medications prescribed for urinary incontinence within 2 weeks prior to the study treatment initiation.
• Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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