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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
External electrical stimulation
Elidah
Monroe, Connecticut, United States
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
Safety Assessed by Number of Serious Adverse Events
Any serious adverse events recorded during the trial.
Time frame: 6 weeks
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
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
Efficacy Assessed by Reduction in Average Bathroom Visits
The efficacy assessed by average bathroom visits during the day and night.
Time frame: 6 weeks
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