Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01512004
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01512004
Study Brief:
Protocol Section:
NCT01512004