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:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT03566134
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 micturition 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:
* Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
* Diagnosed with interstitial cystitis or bladder pain syndrome
* Clinically significant pelvic organ prolapse
* Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
* Medical history of malignant tumor in urinary system or pelvic organs
* Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03566134
Study Brief:
Protocol Section:
NCT03566134