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

NCT06161506 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Urinary Urge Incontinence
  • Stress Urinary Incontinence
  • Prostatic Hyperplasia

Interventions

DEVICE

Elidah 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Deborah E Citrin, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2027-12-01
Completion
2028-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161506 on ClinicalTrials.gov