Back to search results

Surface Electrical Stimulation for Urinary Incontinence After Prostate Cancer Treatment

This study is testing a device called Elidah for men who experience urinary incontinence (leaking urine) after prostate cancer treatment. The Elidah device uses gentle electrical impulses to stimulate muscles in the pelvic area. Researchers want to see if using the Elidah device can reduce urinary incontinence in men. You may be able to join if you are a man, aged 18 or older, and have had urinary incontinence for at least 6 months after prostate cancer treatment. The study aims to measure how well the Elidah device works by comparing your incontinence levels before and after treatment. The current status of this study is unclear, and it plans to enroll 41 participants.

Study design
This is an interventional study planning to enroll 41 male participants. It is not specified if it is randomized or blinded.
What's involved
You would be in the study for about 9 weeks, which includes screening, a physical exam, urine tests, and using the Elidah device.
Compensation
Not stated in the trial record.
Follow-up
Your urinary incontinence will be measured at the beginning of the study and again within two weeks after you finish treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06161506

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~41 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Elidah Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To describe the efficacy of the Elidah device treatment on male urinary incontinence
Measured over Baseline and within 2 weeks after completing treatment

Conditions

Urinary Urge Incontinence
Stress Urinary Incontinence
Prostatic Hyperplasia

Explore related trials

Prostate CarcinomaUrinary Incontinence

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

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

Who to contact

Debbie-Ann N Nathan, R.N.
[email protected]
(240) 858-3103
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To describe the efficacy of the Elidah device treatment on male urinary incontinenceBaseline and within 2 weeks after completing treatment

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