Urinary Urge IncontinencePhase 2NCT06161506
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
A Phase 2 study testing Elidah Device in people with Urinary Urge Incontinence and Stress Urinary Incontinence, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Urinary Urge Incontinence, Stress Urinary Incontinence, Prostatic Hyperplasia
- What is being tested?
- Elidah Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Elidah Device
- Keywords
- Elidah Device, Urinary Incontinence, Prostate Cancer
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence, Stress, Prostatic Hyperplasia, Urinary Incontinence, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elidah DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1/Elidah Device | Experimental | Elidah device application. Receives: Device: Elidah Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and within 2 weeks after completing treatment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 week visit and end of treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Feb 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge IncontinenceStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Deborah E Citrin, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161506
- Sponsor's protocol ID
- 10001713
- Other IDs
- 001713-C
- Status last verified
- 27 Oct 2026
- First submitted
- 1 Dec 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
- ClinicalTrials.gov ID
- NCT06161506
- Acronym / sponsor ID
- 10001713
- Keywords
- Elidah Device, Urinary Incontinence, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Elidah Device | Experimental | Device: Elidah DeviceElidah device application. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elidah DeviceThe 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. | Device | 1/Elidah Device |
Primary outcome
To describe the efficacy of the Elidah device treatment on male urinary incontinence
Time frame: Baseline and within 2 weeks after completing treatment
Percent decrease in 24-hour pad weight after treatment with the Elidah device.
4 secondary outcomes
To assess the safety of the Elidah device in men with urinary incontinence
Time frame: 3 week visit and end of treatment visit
To assess alternative measures of efficacy of Elidah device on male urinary incontinence and bother
Time frame: Baseline and at end of treatment visit
To assess participant-reported outcomes of Elidah device use for male urinary incontinence
Time frame: Baseline and at end of treatment visit
To assess treatment compliance with the Elidah device
Time frame: 3 week visit and end of treatment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah E Citrin, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elidah Device in people with Urinary Urge Incontinence and Stress Urinary Incontinence, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debbie-Ann N Nathan, R.N. ((240) 858-3103, dnathan@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the efficacy of the Elidah device treatment on male urinary incontinence (time frame: Baseline and within 2 weeks after completing treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.