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

NCT06161506 | Recruiting Phase 2

• 2 other identifiers: 10001713001713-C
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Stress Urinary Incontinence; Urinary Urge Incontinence; Prostatic Hyperplasia

Keywords

Elidah Device; Urinary Incontinence; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To describe the efficacy of the Elidah device treatment on male urinary incontinence

  Percent decrease in 24-hour pad weight after treatment with the Elidah device.

  Baseline and within 2 weeks after completing treatment

Secondary Outcomes (4)

• To assess the safety of the Elidah device in men with urinary incontinence

  3 week visit and end of treatment visit

• To assess alternative measures of efficacy of Elidah device on male urinary incontinence and bother

  Baseline and at end of treatment visit

• To assess participant-reported outcomes of Elidah device use for male urinary incontinence

  Baseline and at end of treatment visit

• To assess treatment compliance with the Elidah device

  3 week visit and end of treatment visit

Study Arms (1)

1/Elidah Device

EXPERIMENTAL

Elidah device application.

Device: Elidah Device

Interventions

Elidah Device 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.

1/Elidah Device

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be male.
• Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment.
• Participants must have at least one of the following types of urinary incontinence:
• stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing
• urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer.
• Participants must have moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening.
• Participants must be able to read and write in English.
• Age \>= 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Change of therapy for prostate cancer planned during the study intervention.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence, Stress; Prostatic Hyperplasia; Urinary Incontinence; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa C Cooley Zgela, R.N.

CONTACT

(301) 451-8905; theresa.cooleyzgela@nih.gov

Deborah E Citrin, M.D.

CONTACT

(240) 760-6206; citrind@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 8, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04-13

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)