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

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ClinicalTrials.gov Identifier: NCT03942549
Recruitment Status : Active, not recruiting
First Posted : May 8, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Collins Medical Trust
Information provided by (Responsible Party):
Ian Fields, Oregon Health and Science University

Study Description
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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
Stress Urinary Incontinence 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
MUS Cohort
This cohort will undergo midurethral sling placement.
 Device: Retropubic midurethral sling
Midurethral sling
Other Name: TVT


Outcome Measures
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Primary Outcome Measures :
  1. Urinary Microbiome [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942549


Locations
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United States, Oregon
Legacy Good Samaritan Hospital
Portland, Oregon, United States, 97210
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Collins Medical Trust
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian Fields, Oregon Health and Science University:
microbiome
cytokine
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders