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This study aims to gain new insights by examining the genomic and epigenomic changes associated with overactive bladder (OAB) in women. It enrolled women over 18 who had urgency urinary incontinence at least three times a week for more than three months. This was a study with no assigned phase and it has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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