Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Active Group A	ELITONE UUI	Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A.
Active Group B	ELITONE UUI	Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.