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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT05211193
Eligibility Criteria:
Inclusion Criteria:
* Women 18 years or older, inclusive
* Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
* Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
* Treatment Satisfaction VAS \<50
* Ability to understand and sign ICF
* Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests
* Subject agreed not to participate in another research study from the time of screening until the final study visit
* Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit
Exclusion Criteria:
* Prior treatment with botulotoxin for OAB
* Previous pharmacotherapy for OAB if \>12 months ago
* Urinary retention with post void residual \> 150ml
* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
* History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05211193
Study Brief:
Protocol Section:
NCT05211193