Actively Recruiting
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-15
41
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be male.
- History of urinary incontinence for at least 6 months after local prostate cancer treatment.
- Presence of stress urinary incontinence or urge urinary incontinence.
- Moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening.
- Ability to read and write in English.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Ability and willingness to sign informed consent.
You will not qualify if you...
- Planned change of therapy for prostate cancer during the study intervention.
- History or symptoms of urinary retention (unless occurred before prostatectomy), extra-urethral incontinence, or overflow incontinence.
- Active urinary tract infection at screening or history of 4 or more urinary tract infections in the previous 12 months.
- History of complete denervation of the pelvic floor.
- Severe obesity with body mass index greater than 35.
- Pelvic pain or painful bladder syndrome.
- Metal implants in the abdominal or pelvic area.
- History of chronic cough with ongoing symptoms.
- Implanted cardiac device, untreated cardiac arrhythmia, or other heart problems.
- History of epilepsy.
- Neurologic or neuromuscular disorder contributing to urinary incontinence.
- Change in medications for urinary incontinence within 2 weeks prior to study start.
- Uncontrolled illness or social situations limiting compliance with study requirements.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Theresa C Cooley Zgela, R.N.
CONTACT
D
Deborah E Citrin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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