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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03942549
Study type Observational [Patient Registry]
Source Oregon Health and Science University
Contact
Status Active, not recruiting
Phase
Start date May 3, 2019
Completion date December 31, 2020

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