Bethesda, MDNCT06161506Now EnrollingIRB Ready

Urinary Urge Incontinence Clinical Trial in Bethesda, MD

Access cutting-edge urinary urge incontinence treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Cancer Institute (NCI)

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related urinary urge incontinence treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Urinary Urge Incontinence Study in Bethesda

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT06161506) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Urinary Urge Incontinence Treatment Options in Bethesda, MD

If you're searching for urinary urge incontinence treatment options in Bethesda, MD, this clinical trial (NCT06161506) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced urinary urge incontinence specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all urinary urge incontinence clinical trials near you to find additional studies recruiting in your area.

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