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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02833402
Eligibility Criteria:
Inclusion Criteria:
* Women over the age of 18 with UUI planning to undergo SNM implantation will be included if they have at least 2 UUI episodes on a baseline 3-day diary.
* Willing and able to complete study visits, questionnaires and diaries
* Women previously treated with OAB medication are permitted to participate, but must be off of all medications for a minimum of 4 weeks prior to the performance of the baseline 3-day bladder diary and baseline assessments. They will be required to stay off any OAB medications for the duration of the study.
Exclusion Criteria:
* Neurologic disease (including multiple sclerosis, spinal cord injury, history of cerebrovascular accident, significant peripheral neuropathy)
* Pregnancy
* History of recurrent UTI in last 6 months by definition (3 culture proven UTI in 1 year or 2 culture proven UTI in 6 month period), or women who are receiving treatment for recurrent UTI
* Prolapse beyond the hymen
* Other contraindication to SNM
* Microscopic hematuria, as defined as 3 or more RBC/hpf on complete microscopic urinary analysis, without appropriate work-up (renal imaging and cystoscopy)
* History of pelvic radiation
* History of previous neuromodulation therapy including intravesical botulinum toxin, sacral neuromodulation or peripheral tibial nerve stimulation.
Deferral Criteria:
* Recent systemic antibiotic exposure (within the past 4 weeks)
* Urinary Tract Infection (UTI) at time of enrollment or sample
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02833402
Study Brief:
Protocol Section:
NCT02833402