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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT02674269
Eligibility Criteria:
Main Inclusion Criteria:
* Female patient 18 to 75 years old diagnosed with idiopathic OAB.
* Patient has symptoms of OAB for ≥ 3 months prior to screening.
* Patient is a non-responder to pharmacologic therapy or has intolerable side effects or is not compliant to the treatment.
* On screening three-day voiding diary- Patient has a frequency of at least 8 micturitions per 24 hours \& Total of ≥3 urgency urinary incontinence (UUI) episodes.
* Patient is willing and able to initiate self catheterization post-treatment, if required.
* Patients has PVR ≤100 ml. Patient with a single PVR of \>100 ml and followed by two consecutive PVR measurements of \<100 ml may be included in the study).
Main Exclusion Criteria:
* Patient currently uses CIC or indwelling catheter to manage their urinary incontinence
* Patient who has clinically significant Bladder Outlet Obstruction (BOO).
* Patient with active urinary tract infection.
* OAB due to any known neurological reason.
* Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening visit.
* Predominance of stress incontinence in the opinion of the investigator, determined by patient history.
* Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening.
* Patient with prior botulinum toxin therapy of any serotype within 12 weeks for any indication.
* Patient with prior use of Botulinum toxin therapy of any serotype for any urological condition.
* Patient with previous pelvic radiation therapy.
* Patient had been treated for two or more UTIs within last 6 months or use of prophylactic antibiotics to prevent chronic UTIs.
* ANY condition identified which may cause overactive bladder symptoms
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02674269
Study Brief:
Protocol Section:
NCT02674269