Stress Urinary Incontinence
Conditions
Keywords
microbiome, cytokine
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.
Interventions
Midurethral sling
Sponsors
Collins Medical Trust
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Microbiome | Six weeks | change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed