This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
311
oral
Site KR00003
Daegu, South Korea
SIte KR00004
Incheon, South Korea
Site KR00001
Jeonam, South Korea
Site KR00002
Jungnam, South Korea
Site KR00005
Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12
Time frame: Baseline and week 12
Percent change in the mean number of urge urinary incontinence episodes per 24 hours
Time frame: Baseline, week 4 and week 12
Change in the mean number of urge urinary incontinence episodes per 24 hours
urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary
Time frame: Baseline, week 4 and week 12
Change in the mean frequency of urination per 24 hours
Time frame: Baseline, week 4 and week 12
Percent change in the mean frequency of urination
Time frame: Baseline, week 4 and week 12
Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours
Time frame: Baseline, week 4 and week 12
Change in the mean number of severe urgency episodes per 24 hours
severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary
Time frame: Baseline, week 4 and week 12
Changes in overactive bladder symptom score (OABSS) questionnaire
Change in total and each of OABSS items
Time frame: Baseline, week 4 and week 12
Changes in short urogenital distress inventory (UDI-6)
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Pusan, South Korea
Site KR00006
Seoul, South Korea
Change in total and each UDI-6 items
Time frame: Baseline, week 4 and week 12
Changes in short incontinence impact questionnaire (IIQ-7)
Change in total and each of IIQ-7 items
Time frame: Baseline, week 4 and week 12
Safety assessed by the incidence and severity of side effects
Time frame: For 12 weeks