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

Oregon Health & Science University (OHSU)

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Device: Retropubic midurethral sling

Study type: Observational

Funder types: Other

Identifiers

NCT03942549

STUDY00019197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 1 patient group

MUS Cohort

Description:

This cohort will undergo midurethral sling placement.

Treatment:

Device: Retropubic midurethral sling