Urge Incontinence
Conditions
Keywords
incontinence, bladder, urge, urgency, stimulation
Brief summary
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.
Detailed description
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.
Interventions
DEVICEELITONE UUI
External electrical stimulation
Sponsors
Elidah, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Device looks identical. A third person masks which software is coded.
Intervention model description
Randomized between two active groups
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically: * An affirmative response to Is it very difficult to control when you have a strong urge to urinate?, * An affirmative or negative response to Do you lose urine with physical activities such as coughing, sneezing, running?, * And, if an affirmative response to the second question, an affirmative response to Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing? * Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4)
Exclusion criteria
* Less than 1 incontinence accident (leak) per day\* * Severe incontinence as determined by self-reported \>5 accidents per day * Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks * Vaginal or pelvic surgery within previous 6 months * Severe Obesity as defined by BMI \>= 35 * Change in incontinence medication type or dosing within the last 3 months. * History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence * Pelvic pain/painful bladder syndrome * Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal) * Tissues protruding outside the vagina at rest * Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions, * Complete denervation of the pelvic floor * Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine, * Chronic coughing * Previous use of Interstim device or Botox for UI * Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems. * Cancer, epilepsy or cognitive dysfunction * Underlying neurologic/neuromuscular disorder * Impaired decision making, suicidal thoughts, or drug/alcohol dependence * Lacks capacity to consent for themselves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Number of Urinary Incontinence Episodes Per Day | 6 weeks | The efficacy of a treatment for urinary incontinence measures how much the treatment changed urinary incontinence leakage from the beginning to the end of the 6 week period. |
| Safety Assessed by Number of Serious Adverse Events | 6 weeks | Any serious adverse events recorded during the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) | 6 weeks | The efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL). The scale is as follows: 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The lower the value the less times it happens and the better outcome. A larger results indicate a higher change in I-QOL from beginning to end of trial. The minimum score total is 22 and maximum total score is 110. |
| Efficacy Assessed by Reduction in Average Pads Used Per Day | 6 weeks | Efficacy Assessed by Reduction in Average Pads used per day over the 6 week period. |
| Efficacy Assessed by Reduction in Average Bathroom Visits | 6 weeks | The efficacy assessed by average bathroom visits during the day and night. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Group A Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A (urge only for 6 seconds/cycle).
ELITONE UUI: External electrical stimulation | 17 |
| Active Group B Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B (urge and stress)
ELITONE UUI: External electrical stimulation | 34 |
| Total | 51 |
Baseline characteristics
| Characteristic | Active Group B | Total | Active Group A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 15 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 36 Participants | 13 Participants |
| Age, Continuous | 57.8 years STANDARD_DEVIATION 12.7 | 56.2 years STANDARD_DEVIATION 13.1 | 53.0 years STANDARD_DEVIATION 13.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 34 participants | 51 participants | 17 participants |
| Sex: Female, Male Female | 34 Participants | 51 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 34 |
| other Total, other adverse events | 0 / 17 | 0 / 34 |
| serious Total, serious adverse events | 0 / 17 | 0 / 34 |
Outcome results
Primary
Change in Average Number of Urinary Incontinence Episodes Per Day
The efficacy of a treatment for urinary incontinence measures how much the treatment changed urinary incontinence leakage from the beginning to the end of the 6 week period.
Time frame: 6 weeks
Population: Total of 82 participants, but only 51 completed the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group A | Change in Average Number of Urinary Incontinence Episodes Per Day | 69.6 percentage change | Standard Deviation 30.9 |
| Active Group B | Change in Average Number of Urinary Incontinence Episodes Per Day | 66.1 percentage change | Standard Deviation 28.7 |
p-value: <0.0001t-test, 2 sided
Primary
Safety Assessed by Number of Serious Adverse Events
Any serious adverse events recorded during the trial.
Time frame: 6 weeks
Population: There were no adverse events for any participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group A | Safety Assessed by Number of Serious Adverse Events | 0 serious adverse events | Standard Deviation 0 |
| Active Group B | Safety Assessed by Number of Serious Adverse Events | 0 serious adverse events | Standard Deviation 0 |
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). The scale is as follows: 1 = not at all , 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The lower the value the less times it happens and the better outcome. A larger results indicate a higher change in I-QOL from beginning to end of trial. The minimum score total is 22 and maximum total score is 110.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group A | Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) | -26.6 change of score on a scale | Standard Deviation 20.2 |
| Active Group B | Efficacy Assessed by Change in Incontinence Quality of Life Questionnaire (I-QOL) | -21.8 change of score on a scale | Standard Deviation 15.9 |
Secondary
Efficacy Assessed by Reduction in Average Bathroom Visits
The efficacy assessed by average bathroom visits during the day and night.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group A | Efficacy Assessed by Reduction in Average Bathroom Visits | 5.9 percentage of change | Standard Deviation 29.5 |
| Active Group B | Efficacy Assessed by Reduction in Average Bathroom Visits | 0.5 percentage of change | Standard Deviation 26 |
Secondary
Efficacy Assessed by Reduction in Average Pads Used Per Day
Efficacy Assessed by Reduction in Average Pads used per day over the 6 week period.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Group A | Efficacy Assessed by Reduction in Average Pads Used Per Day | 27.8 percentage of change | Standard Deviation 57.4 |
| Active Group B | Efficacy Assessed by Reduction in Average Pads Used Per Day | 36.4 percentage of change | Standard Deviation 33.5 |