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

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MUS Cohort; This cohort will undergo midurethral sling placement.	Device: Retropubic midurethral sling; Midurethral sling; Other Names: TVT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Microbiome	change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of overactive bladder symptoms	Validated symptom questionnaires will be collected at baseline and again at 2 and six weeks postoperatively to assess common symptoms associated with overactive bladder.	Six weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Collins Medical Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: microbiome; cytokine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: STUDY00019197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No