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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03057158
Eligibility Criteria:
Inclusion criteria:
* Women over the age of 18.
* Urgency incontinence (at least 3 times per week) for \> 3months
* History of elevated A1C or Type II diabetes (UUI+IR and IR only groups)
* Non-pregnant
* At least 6 months since most recent childbirth
Exclusion criteria:
* Active pregnancy, or within 6 months of childbirth
* Breastfeeding
* Proteinuria (defined as \>1+ protein on urine dipstick in the absence of infection)
* Gross hematuria (in the absence of UTI)
* Type I diabetes mellitus
* Type II diabetes with chronic renal impairment (Cr \>1.5)
* Chronic renal disease (includes vasculitis, focal segmental glomerulosclerosis, lupus nephritis, polycystic kidney disease, nephropathy)
* Receiving chemotherapy or radiation for malignancy
* Taking one of the following drugs that influence DNA methylation: hydralazine, procainamide, methotrexate, valproic acid, tamoxifen, raloxifene, letrozole, anastrozole (Arimidex), or exemestane (Aromasin)
* Any history of urinary tract malignancy (bladder, urethra, ureter, kidney)
* Intradetrusor Botox injection within the prior 12 months
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03057158
Study Brief:
Protocol Section:
NCT03057158