Stress Urinary Incontinence
Conditions
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.
Interventions
DEVICETranscutaneous electrical stimulation (Elitone)
Transcutaneous perineal area electrical stimulation
Sponsors
Elidah, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The device looks identical, but the waveform is different. Randomization, programming and recording of which waveform is done by a third party separate from those listed above.
Intervention model description
Randomization
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes | 12 weeks | The percent reduction in average number of urinary incontinence episodes over 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessed by Percent Reduction in Average Pad Weight | 12 weeks | The percent reduction of pad weight in a day over the 12 weeks. |
| Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) | 12 weeks | The efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL). It comprises 22 questions, to which the subject provides a numeric response on a 1-5 scale. 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The score is the sum of the numeric responses, which can range from 22 to 110. The lower the value the less times it happens and the better outcome. |
| Pads Per Day | 12 weeks | Reduction of number of pads used per day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Elitone Surface electrical stimulation with a treatment waveform (medium frequency modulated at 50Hz)
Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation | 35 |
| Control Elitone Sham surface electrical stimulation at a very low frequency not known to contract muscles.
Transcutaneous electrical stimulation (Elitone): Transcutaneous perineal area electrical stimulation | 13 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed Intervetion | Lost to Follow-up | 11 | 7 |
| Completed Intervetion | Withdrawal by Subject | 6 | 5 |
| Included in Analysis | Protocol Violation | 5 | 5 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 13.3 | 47.6 years STANDARD_DEVIATION 12 | 44.7 years STANDARD_DEVIATION 7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 35 participants | 48 participants | 13 participants |
| Sex: Female, Male Female | 35 Participants | 48 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stress incontinence leaks/day | 2.81 leaks/day STANDARD_DEVIATION 1.01 | 2.76 leaks/day STANDARD_DEVIATION 1.05 | 2.65 leaks/day STANDARD_DEVIATION 1.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 13 |
| other Total, other adverse events | 1 / 35 | 0 / 13 |
| serious Total, serious adverse events | 0 / 35 | 0 / 13 |
Outcome results
Primary
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes
The percent reduction in average number of urinary incontinence episodes over 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes | 52.8 percent reduction in leaks/day | Standard Deviation 36.3 |
| Control | Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes | 7.9 percent reduction in leaks/day | Standard Deviation 55.9 |
Secondary
Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL)
The efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL). It comprises 22 questions, to which the subject provides a numeric response on a 1-5 scale. 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The score is the sum of the numeric responses, which can range from 22 to 110. The lower the value the less times it happens and the better outcome.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) | 20.8 Change of score on a scale | Standard Deviation 20.8 |
| Control | Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) | 10.3 Change of score on a scale | Standard Deviation 21.8 |
Secondary
Efficacy Assessed by Percent Reduction in Average Pad Weight
The percent reduction of pad weight in a day over the 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Efficacy Assessed by Percent Reduction in Average Pad Weight | 38.3 percentage reduction in pad weight | Standard Deviation 62.4 |
| Control | Efficacy Assessed by Percent Reduction in Average Pad Weight | 25.3 percentage reduction in pad weight | Standard Deviation 48.8 |
Secondary
Pads Per Day
Reduction of number of pads used per day
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Pads Per Day | 35.0 percentage reduction | Standard Deviation 34.1 |
| Control | Pads Per Day | 8.2 percentage reduction | Standard Deviation 59.9 |