NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)



Elidah Device;
Urinary Incontinence;
Prostate Cancer

Recruitment Keyword(s)



Urinary Urge Incontinence;
Stress Urinary Incontinence;
Prostatic Hyperplasia

Investigational Drug(s)


Investigational Device(s)



Device: Elidah Device

Supporting Site

National Cancer Institute


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.


To see if the Elidah device can reduce urinary incontinence after prostate treatment.


Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer.


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.

--Back to Top--



- 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 1-5 leaks per day and use at least 1 pad 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.


- 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.

- 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.

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Deborah E. Citrin, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3532
(240) 760-6206

Theresa Cooley Zgela, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2-5530
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8905

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


--Back to Top--