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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT01043666
Eligibility Criteria:
Inclusion Criteria:
* Subjects with symptoms of overactive bladder for at least 12 weeks before the study
* Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
* Subject with an average frequency of micturition of 8 or more times per 24-hour period
* Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
* Subject having provided written informed consent by him/herself
Exclusion Criteria:
* Subject having stress urinary incontinence as a predominant symptom
* Subject with transient symptoms suspected for overactive bladder
* Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
* Subject complicated with bladder tumor/prostatic tumor or with the historical condition
* Subject confirmed to have a post-void residual volume of \>=100ml or with a clinically significant lower urinary tract obstructive disease
* Subject with indwelling catheter or practicing intermittent self-catheterization
* Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
* Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
* Subject with uncontrolled hypertension (indicated by sitting SBP \>=180mmHg or DPB \>= 110mmHg)
* Subject with a pulse rate \>= 110bpm or \<50 bpm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01043666
Study Brief:
Protocol Section:
NCT01043666