Genomics and Epigenomics for New Insights in fEmale OAB (GENIE) Study
Completed
Conditions studied: Overactive Bladder, Insulin Resistance
In brief
Millions of women suffer from overactive bladder, and the changes in bladder function affect their quality of life. The study team believes that it needs to be better understand why women get overactive bladder in the first place so that better treatments can eventually be offered. The purpose of this study is to determine why women with insulin resistance are more likely to get overactive bladder. Overactive bladder is a type of bladder control problem that can cause some women to have bladder leakage. This problem is more common in women with diabetes and pre-diabetes, but it isn't known why.
Key facts
- Study ID
- NCT03057158
- Run by
- Duke University
- People needed
- 257
- Starts
- 2017-05-01
- Expected to finish
- 2020-03-11
- Last updated by the study team
- 2020-09-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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