Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence

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.

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.