Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Retropubic midurethral sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Planning to undergo retropubic midurethral sling placement Exclusion Criteria: 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 Pregnancy History of pelvic radiation or bladder cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MUS Cohort<br>This cohort will undergo midurethral sling placement. | Device: Retropubic midurethral sling<br>* Midurethral sling<br>* Other names: TVT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Microbiome | change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of overactive bladder symptoms | Validated symptom questionnaires will be collected at baseline and again at 2 and six weeks postoperatively to assess common symptoms associated with overactive bladder. | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, cytokine