BEMOR: Bladder Environment: Microbiome Oxygen Relationship

Sponsor
Loyola University (Other)
Overall Status
Completed
CT.gov ID
NCT02868463
Collaborator
Alan J. Wolfe (Other)
115
1
14.5
7.9

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize bladder urinary oxygen tension (BUOT) in women whose urinary microbiomes contains at least one anaerobic bacterial species versus women whose urinary microbiomes do not contain anaerobes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Throughout the human body, microbial communities (microbiota) depend on their environment, including the level of oxygen (anaerobic vs. aerobic). Recently published evidence documents the existence of a female urinary microbiota (FUM) and provides evidence that the FUM differ based on lower urinary tract symptoms, i.e. no bladder symptoms, urgency urinary incontinence, and urinary tract infection1-4. Members of the FUM include bacteria that require oxygen (aerobes), those that abhor oxygen (anaerobes) and those that thrive in both conditions (facultative anaerobes)5. This last group of microbes is known to consume low levels of oxygen to maintain an anaerobic environment. Yet, virtually nothing is known about oxygen levels in bladder urine even though bladder urine oxygen tension may both affect and be affected by the FUM. Given the role oxygen levels play in other parts of the human body, the investigators request resources to investigate bladder urine oxygen levels. The study is designed to understand if BUOT levels differ in FUMs with and without at least one anaerobe, and if so, if there are any patient factors or urinary symptoms associated with certain BUOT

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    115 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Bladder Environment: Microbiome Oxygen Relationship
    Actual Study Start Date :
    Jun 2, 2016
    Actual Primary Completion Date :
    Aug 17, 2017
    Actual Study Completion Date :
    Aug 17, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Oxygen Tension Measurement of Bladder Urine and Correlation of These Oxygen Profiles with Expanded Urine Culture Bacterial Growth in Women [The study completion is expected at 2 years.]

      Throughout the human body, microbial communities (microbiota) depend on their environment, including the level of oxygen (anaerobic vs. aerobic). Recently published evidence documents the existence of a female urinary microbiota (FUM) and provides evidence that the FUM differ based on lower urinary tract symptoms, i.e. no bladder symptoms, urgency urinary incontinence, and urinary tract infection. Members of the FUM include bacteria that require oxygen (aerobes), those that abhor oxygen (anaerobes) and those that thrive in both conditions (facultative anaerobes). This last group of microbes is known to consume low levels of oxygen to maintain an anaerobic environment. Yet, virtually nothing is known about oxygen levels in bladder urine even though bladder urine oxygen tension may both affect and be affected by the FUM.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age > 18

    • No indwelling urethral catheter

    • At least 50 mL of urine in their bladder as determined by the clinic's bladder scanner

    Exclusion Criteria:
    • Non-English speaker

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loyola University Health System Maywood Illinois United States 60153

    Sponsors and Collaborators

    • Loyola University
    • Alan J. Wolfe

    Investigators

    • Principal Investigator: Elizabeth R Mueller, MD, Loyola University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Elizabeth Mueller, MD, Professor, Loyola University
    ClinicalTrials.gov Identifier:
    NCT02868463
    Other Study ID Numbers:
    • 208221
    First Posted:
    Aug 16, 2016
    Last Update Posted:
    Feb 20, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Elizabeth Mueller, MD, Professor, Loyola University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 20, 2018