RECRUITING

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

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Conditions

Urinary Urge IncontinenceStress Urinary IncontinenceProstatic HyperplasiaElidah DeviceUrinary IncontinenceProstate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-15
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06161506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be male.
  2. * Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment.
  3. * Participants must have at least one of the following types of urinary incontinence:
  4. * stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing
  5. * urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer.
  6. * Participants must have moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening.
  7. * Participants must be able to read and write in English.
  8. * Age \>= 18 years.
  9. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
  10. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Change of therapy for prostate cancer planned during the study intervention.
  2. * History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence.
  3. * 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).
  4. * History of complete denervation of the pelvic floor.
  5. * Severe obesity (body mass index \[BMI\] \>35).
  6. * Pelvic pain/painful bladder syndrome.
  7. * Metal implant in the abdominal or pelvic area.
  8. * History of chronic cough with ongoing symptoms
  9. * An implanted cardiac device, history of untreated cardiac arrhythmia, or history of other heart problems.
  10. * History of epilepsy.
  11. * History of underlying neurologic/neuromuscular disorder that could contribute to urinary incontinence.
  12. * Change in medications prescribed for urinary incontinence within 2 weeks prior to the study treatment initiation.
  13. * Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.

Contacts and Locations

Study Contact

Theresa Cooley Zgela, R.N.
CONTACT
(301) 451-8905
tcooley@mail.nih.gov
Deborah E Citrin, M.D.
CONTACT
(240) 760-6206
citrind@mail.nih.gov

Principal Investigator

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

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-15
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2024-02-15
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Elidah Device
  • Urinary Incontinence
  • Prostate Cancer

Additional Relevant MeSH Terms

  • Urinary Urge Incontinence
  • Stress Urinary Incontinence
  • Prostatic Hyperplasia