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

Sponsor
Oregon Health and Science University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03942549
Collaborator
Collins Medical Trust (Other)
20
Enrollment
2
Locations
20
Anticipated Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Retropubic midurethral sling

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
Actual Study Start Date :
May 3, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
MUS Cohort

This cohort will undergo midurethral sling placement.

Device: Retropubic midurethral sling
Midurethral sling
Other Names:
  • TVT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Urinary Microbiome [Six weeks]

      change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Legacy Good Samaritan Hospital Portland Oregon United States 97210
    2 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • Collins Medical Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ian Fields, Principal Investigator, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT03942549
    Other Study ID Numbers:
    • STUDY00019197
    First Posted:
    May 8, 2019
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ian Fields, Principal Investigator, Oregon Health and Science University
    microbiome
    cytokine
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Sep 16, 2020