Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer (NCT06161506) | Clinical Trial Compass
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
United States41 participantsStarted 2024-02-15
Plain-language 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.
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.
Who can participate
Age range
18 Years – 120 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To describe the efficacy of the Elidah device treatment on male urinary incontinence
Timeframe: Baseline and within 2 weeks after completing treatment