Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be male.
Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Elidah Device
DeviceThe Elidah device is a modified version of the FDA approved ELITONE device cleared for use in the treatment of female stress urinary incontinence. For the current study, only minor modifications have been implemented with respect to the shape of the electrode component, providing a contour better suited to fit the male anatomy.
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: 1/Elidah DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To describe the efficacy of the Elidah device treatment on male urinary incontinence
Percent decrease in 24-hour pad weight after treatment with the Elidah device.
Time frame
Baseline and within 2 weeks after completing treatmentSecondary outcomes
1
To assess the safety of the Elidah device in men with urinary incontinence
Frequency of adverse events among treated participants and reporting the results, by maximum grade of event and type of toxicity noted.
Time frame
3 week visit and end of treatment visit2
To assess alternative measures of efficacy of Elidah device on male urinary incontinence and bother
Evaluated by the number of pads and number of leaks before and after treatment. The mean of the percent reduction in the number of pads used per day following treatment will be computed along with 95% confidence intervals.
Time frame
Baseline and at end of treatment visit3
To assess participant-reported outcomes of Elidah device use for male urinary incontinence
The proportion of participants for which the I-QoL score improves by 2.5 points or more following six weeks of Elidah device use will be estimated. 95% confidence intervals for this proportion will be constructed.
Time frame
Baseline and at end of treatment visit4
To assess treatment compliance with the Elidah device
A test of binomial proportions will be performed to assess whether the treatment noncompliance rate is above the unacceptability threshold.
Time frame
3 week visit and end of treatment visitSponsors and contacts
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Source ClinicalTrials.gov