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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT05282069
Eligibility Criteria:
Inclusion Criteria:
Main Inclusion at Screening (Visit 1):
* Men and women 19 years or older with OAB symptoms for ≥ 3 months.
* Subject who is willing and able to complete the voiding diary correctly.
* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Exclusion Criteria:
Main Exclusion at Screening (Visit 1):
* Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
* Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
* Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
* Clinically significant benign prostatic hyperplasia at the discretion of the investigator
* Had bladder or lower urinary tract surgery within 12 months from the screening visit
* Medical history of malignant tumor in urinary system or pelvic organs
* \>150 mL of post-void residual volume in the screening test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05282069
Study Brief:
Protocol Section:
NCT05282069