Status:
COMPLETED
Stress Incontinence Trial With Elitone Device
Lead Sponsor:
Elidah, Inc.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
21-75 years
Phase:
NA
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 epi...
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 treatme...
Eligibility Criteria
Inclusion
- Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03782116
Start Date
September 1 2018
End Date
March 31 2019
Last Update
January 13 2025
Active Locations (1)
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1
Nationwide At-Home study
Monroe, Connecticut, United States, 06468