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

A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostatic Hyperplasia; Stress Urinary Incontinence; Urinary Urge Incontinence
• Intervention / Treatment: Device: Elidah Device

Detailed Description

Background:

• Urinary incontinence is a common side effect of prostate cancer therapy that can negatively impact the quality of life.
• Standard treatment includes an initial course of pelvic floor muscle exercises followed by surgical therapy if urinary incontinence persists.
• Although pelvic floor muscle exercises can be successful in reducing urinary incontinence, compliance with exercises is poor.
• The Elitone (registered trademark) device was recently cleared by the Food and Drug Administration (FDA) for use in women with stress urinary incontinence. This device provides a surface electrical muscle stimulation device designed to contract the pelvic floor muscles and has been shown to reduce incontinence in women using the product.
• Recently, the electrode component (GelPad) of the device has been adapted for use in men by the manufacturing company, Elidah. The male version of the device is named the Elidah device.

Objective:

-To describe the efficacy of the Elidah device on male urinary incontinence

Eligibility:

• Participants must be male.
• Participants must have a history of urinary incontinence for at least 6 months after 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.

Design:

• This is a phase II trial testing the efficacy of the Elidah device in people treated for prostate cancer with stress and/or urge urinary incontinence.
• Prior to treatment, participants will undergo baseline assessments including 24-hour pad weight testing and questionnaires relating to incontinence and quality of life.
• Participants will self-administer the Elidah device treatment for 20 minutes per day, 5 days per week during a 6-week period in the at-home environment. Participants will maintain a Daily Log to record usage of the Elidah device, urinary leaks, and use of pads during each week of treatment.
• Following 6 weeks of therapy, participants will undergo re-evaluation of symptoms and urinary incontinence via questionnaires and testing with the 24-hour pad weight test.

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Deborah E Citrin, M.D.; Phone Number: (240) 760-6206; Email: citrind@mail.nih.gov
• Study Contact Backup: Name: Theresa C Cooley Zgela, R.N.; Phone Number: (301) 451-8905; Email: theresa.cooleyzgela@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: National Cancer Institute Referral Office; Phone Number: 888-624-1937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• INCLUSION CRITERIA:
• 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.

EXCLUSION CRITERIA:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1/Elidah Device; Elidah device application.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety of the Elidah device in men with urinary incontinence	Frequency of adverse events among treated participants and reporting the results, by maximum grade of event and type of toxicity noted.	3 week visit and end of treatment visit
To assess alternative measures of efficacy of Elidah device on male urinary incontinence and bother	Evaluated by the number of pads and number of leaks before and after treatment. The mean of the percent reduction in the number of pads used per day following treatment will be computed along with 95% confidence intervals.	Baseline and at end of treatment visit
To assess participant-reported outcomes of Elidah device use for male urinary incontinence	The proportion of participants for which the I-QoL score improves by 2.5 points or more following six weeks of Elidah device use will be estimated. 95% confidence intervals for this proportion will be constructed.	Baseline and at end of treatment visit
To assess treatment compliance with the Elidah device	A test of binomial proportions will be performed to assess whether the treatment noncompliance rate is above the unacceptability threshold.	3 week visit and end of treatment visit

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Deborah E Citrin, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 13, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Urinary Incontinence; Elidah Device
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Urinary Incontinence; Urinary Incontinence, Stress; Prostatic Hyperplasia; Urinary Incontinence, Urge
• Other Study ID Numbers: 10001713; 001713-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No