Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
NCT ID: NCT03942549
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2019-05-03
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MUS Cohort
This cohort will undergo midurethral sling placement.
Retropubic midurethral sling
Midurethral sling
Interventions
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Retropubic midurethral sling
Midurethral sling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning to undergo retropubic midurethral sling placement
Exclusion Criteria
* 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
* Pregnancy
* History of pelvic radiation or bladder cancer
18 Years
89 Years
FEMALE
Yes
Sponsors
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Collins Medical Trust
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Ian Fields
Principal Investigator
Locations
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Legacy Good Samaritan Hospital
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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STUDY00019197
Identifier Type: -
Identifier Source: org_study_id
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