This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
97
Device Programming
Academic Urology & Urogynecology of Arizona
Phoenix, Arizona, United States
East Coast Institute for Research
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
Time frame: 12 weeks
Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.
International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.
Time frame: 12 weeks
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