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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01578304
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients with overactive bladder aged 20 years or more
* subject who had the continuos symptom for 3 months or more
* subject prepare a symptom diary and was deemed eligible for the study by the investigator
* 8 times or more of daily mean urination frequency
* 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency
Exclusion Criteria:
* subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
* subjects with diseases prohibiting anti-cholinergics from administration
* subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
* subjects who received lower urinary tract surgery within 6 months
* subjects with a catheter placed or intermittent catheterization
* subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period
* subjects who are within 1 month after other clinical study was completed
* subjects having 100mL or more of residual urine
* subjects who had acute urinary retention history
* subjects who have been administered Prohibited concomitant medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01578304
Study Brief:
Protocol Section:
NCT01578304