Clinical trial NCT03942549: Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
Official title: Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence
Keywords: microbiome
cytokine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Collins Medical Trust
First posted: 2019-05-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include women over the age of 18 planning to undergo stand-alone midurethral sling placement for treatment of stress urinary incontinence.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Microbiome
timeFrame: Six weeks
Secondary outcomes:
measure: Prevalence of overactive bladder symptoms
timeFrame: Six weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: