Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Recruitment & Eligibility

Inclusion Criteria

Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB>3 months subject has urinary frequency (average micturition frequency within 24h>8 times), urgency and/or urge incontinence by micturition diary card during screening period
Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
The subject is willing and able to complete the micturition diary card correctly
Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form

Exclusion Criteria

Confirmed by the investigator that subject has severe stress incontinence.
Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
Subject who has a symptomatic acute urinary tract infection.
Subject who has a recurrent urinary tract infection.
Subject who has interstitial cystitis.
Subject who has an agnogenic hematuria.
Subject who has a bladder outlet obstruction of clinical significance.
Subject who needs retention catheterization or intermittent catheterization.
Patient with malignant tumor.
Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.
Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.
Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.

Study & Design

Arm && Interventions

Group	Intervention	Description
Tolterodine Extended-release Tablet	Tolterodine Extended-release Tablet	4mg/tablet; oral; once per day
Propiverine Hydrochloride Extended-Release Capsule	Propiverine Hydrochloride	30 mg/capsule; oral; once per day

Primary Outcome Measures

Name	Time	Method
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record	prior to medication and 8 weeks after medication	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

Secondary Outcome Measures

Name	Time	Method
The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record	prior to medication, 2 weeks and 8 weeks after medication	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.

Recruitment & Eligibility