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OncoMatch/Clinical Trials/NCT06161506

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

Is NCT06161506 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Elidah Device for urinary urge incontinence.

Phase 2RecruitingNational Cancer Institute (NCI)NCT06161506Data as of Jun 2026

Treatment: Elidah DeviceBackground: 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.

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Extracted eligibility criteria

Treatments studied

Other

Elidah Device

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 120
Male only

Prior therapy

Must have received: local prostate cancer treatment

history of urinary incontinence for at least 6 months after local prostate cancer treatment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • National Institutes of Health Clinical Center · Bethesda, Maryland

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Frequently asked questions

Is NCT06161506 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received local prostate cancer treatment.

Is there an age limit?

Yes. Patients must be 120 years or younger.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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