Clinical trial NCT03782116: Stress Incontinence Trial With Elitone Device
Official title: Randomized Controlled Study of Efficacy of Elitone Device For the Treatment of Mild-Moderate Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Elidah, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 87
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.

Detailed description: The Elitone device delivers electrical muscle stimulation to pelvic floor muscles through a disposable surface electrode shaped to fit the perineal region. In typical use women self-administer treatment 20 minutes per day, 5x per week, for 6-12 weeks. Elidah is initiating a prospective, randomized clinical study to demonstrate device efficacy. The study expands a similar pilot to 60 subjects, adds a control arm (sham device) and includes additional outcome measures. Like the earlier study, subjects will self-administer treatment over multiple weeks while maintaining daily logs of their treatment and incontinence symptoms. This is a home-use study, which does not require clinic visits. Accordingly, this allows subject recruitment from across US.

Eligibility criteria: Inclusion Criteria:

Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.

Exclusion Criteria:

* Severe incontinence as determined by self-reported \>5 accidents in 24-hr period
* Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
* Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
* Cancer, epilepsy or cognitive dysfunction
* Vaginal or pelvic surgery within previous 6 months
* Complete denervation of the pelvic floor
* History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
* Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year)
* Recurrent vaginitis (bacterial/fungal)
* Pelvic pain/painful bladder syndrome
* Underlying neurologic/neuromuscular disorder
* Severe Obesity as defined by BMI \>= 35
* Chronic coughing
* Impaired decision making, drug or alcohol dependence, or suicidal thoughts.
* Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.

Primary outcomes:
measure: Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy Assessed by Percent Reduction in Average Pad Weight
timeFrame: 12 weeks
measure: Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
timeFrame: 12 weeks
measure: Pads Per Day
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Monroe
country: United States
facility: Nationwide At-Home study
state: Connecticut
Study officials:
References: