This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Transcutaneous electrical nerve stimulation
Stanford University Medical Center
Palo Alto, California, United States
Change in Urge Incontinence Episodes
Time frame: Baseline and 8 weeks
Change in Micturitions Per Day
Mean number of urinary voids per day (taken over a 3-day period)
Time frame: Baseline and 8 weeks
Change in Health-related Quality of Life (HRQL)
Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.
Time frame: Baseline and 8 weeks
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