- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03942549
Recruitment Status Active, not recruiting
First Posted May 8, 2019
Last update posted September 16, 2020
This observational cohort study is aimed at determining changes in the cytokine expression profile as well as the urinary and vaginal microbiome of women undergoing midurethral sling placement for the treatment of stress urinary incontinence.
Primary Objectives: This is a pilot study to evaluate how midurethral sling (MUS) placement for the treatment of stress urinary incontinence (SUI) affects the bladder microenvironment, specifically the local microbial community or "microbiome" of the bladder and the cytokine expression profile. The investigators also aim to correlate any changes in the microbiome or cytokine expression profile with patient-reported urinary symptoms preoperatively and postoperatively. Specific Aim 1: Assess the change in the urinary and vaginal microbiome (preoperatively to postoperatively) in women undergoing MUS placement for the treatment of SUI. The investigators hypothesize that the bladder environment will be disturbed by surgery involving the lower urinary tract and will show demonstrable changes in the urinary and vaginal microbiota. Specific Aim 2: Characterize the cytokine profile of the bladder (preoperatively to postoperatively) in women undergoing MUS placement for the treatment of SUI. The investigators hypothesize that MUS treatment will change the cytokine profile of the bladder and lead to alterations in the expression of pro-inflammatory cytokines.
|: MUS Cohort
This cohort will undergo midurethral sling placement.
Device: Retropubic midurethral sling
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Age > 18 years old
- Planning to undergo retropubic midurethral sling placement
- Prior surgery for stress urinary incontinence
- Untreated pelvic organ prolapse > Stage II based on POP-Q assessment
- Concomitant surgery for prolapse
- Current use of anticholinergic medications
- Use of systemic or vaginal antibiotics in the last 2 months
- Active urinary tract infection
- History of recurrent UTI
- History of pelvic radiation or bladder cancer
United States, Oregon
Legacy Good Samaritan Hospital
United States, Oregon
Oregon Health & Science University
Oregon Health and Science University
Collins Medical Trust