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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02995967
Eligibility Criteria:
Inclusion Criteria:
* Women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. Patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin A treatment in the study
* Female ≥ 18 years old
* Desires further treatment for OAB symptoms.
* Express understanding and ability to perform clean intermittent self-catheterization (CISC) if required.
* Ability to consent
* Ability to complete all study related items and interviews
Exclusion Criteria:
* Post void residual urine volume \> 150 mL as assessed by catheter or ultrasound
* History of intradetrusor botulinum toxin A injection
* History of or current cancer of the genitourinary or gynecology tract
* Neurogenic bladder
* Interstitial cystitis
* Current urinary tract infection (can be treated and re-considered for study)
* Current active sacral neuromodulation device
* Non-English speaking
* History of chronic pelvic pain
* Hematuria not previously evaluated
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02995967
Study Brief:
Protocol Section:
NCT02995967