The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
324
drug of oral capsule
4mg/tablet; oral; once per day
Beijing Chaoyang Hospital
Beijing, China
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication
Time frame: prior to medication and 8 weeks after medication
The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record
The alteration of mean incontinence frequency, mean micturition frequency and volume within 24 hous on the basis of continuous 3-day record,prior to medication, 2 weeks and 8 weeks after medication. Additionaly, to evaluate the subject's feeling of treatment benefit and the time of the drug effect onset.
Time frame: prior to medication, 2 weeks and 8 weeks after medication
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