Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: Retropubic midurethral sling
- Registration Number
- NCT03942549
- Lead Sponsor
- Oregon Health and Science University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
- 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
- Pregnancy
- History of pelvic radiation or bladder cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MUS Cohort Retropubic midurethral sling This cohort will undergo midurethral sling placement.
- Primary Outcome Measures
Name Time Method Urinary Microbiome Six weeks change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative
- Secondary Outcome Measures
Name Time Method Prevalence of overactive bladder symptoms Six weeks Validated symptom questionnaires will be collected at baseline and again at 2 and six weeks postoperatively to assess common symptoms associated with overactive bladder.
Trial Locations
- Locations (2)
Legacy Good Samaritan Hospital
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States