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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03942549

Recruitment Status Active, not recruiting

First Posted May 8, 2019

Last update posted September 16, 2020

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:Stress Urinary Incontinence
  • Intervention/Treatment: Device: Retropubic midurethral sling
  • Phase: N/A
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]
  • Estimated 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: MUS Cohort
This cohort will undergo midurethral sling placement.
Device: Retropubic midurethral sling
Midurethral sling
Outcome Measures
  • 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
  • Ages Eligible for Study: 18 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
Contacts
Locations

United States, Oregon
Legacy Good Samaritan Hospital
Portland

United States, Oregon
Oregon Health & Science University
Portland

Sponsors and Collaborators

Oregon Health and Science University

Collins Medical Trust

More Information
  • Responsible Party: Oregon Health and Science University
  • ClinicalTrials.gov Identifier: NCT03942549 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Oregon Health and Science University: microbiome cytokine
  • Additional relevant MeSH terms: Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress