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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06226220
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant women \>/=18 years old undergoing sacral neuromodulation (SNM) treatment for urgency urinary incontinence (UUI) or urgency-frequency (UF) who have elected to undergo testing phase with a PNE
* \>/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing \>/=50% of total incontinence episodes recorded or \>/=8 per day for 2 days on a 3-day bladder diary
* Willing and able to complete all study related items and interviews
* Grossly neurologically normal exam
Exclusion Criteria:
* SNM indication of non-obstructive urinary retention or isolated fecal incontinence
* Severe or poorly controlled diabetes (defined as HgbA1c \>/=8.0) or diabetes with peripheral nerve involvement
* Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury
* Surgically altered detrusor muscle (i.e. Augmentation cystoplasty)
* Current or prior bladder malignancy
* Prior pelvic irradiation
* Post void residual (PVR) \>/= 150 mL within 6 months prior to enrollment
* Active urinary tract infection
* Primary stress urinary incontinence or mixed urinary incontinence with stress predominance
* \>/= Stage III pelvic organ or vaginal vault prolapse and/or current pessary use
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06226220
Study Brief:
Protocol Section:
NCT06226220