Bladder Environment: Microbiome Oxygen Relationship (BEMOR)

February 19, 2018 updated by: Elizabeth Mueller, Loyola University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female only participants are being studied

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Tension Measurement of Bladder Urine and Correlation of These Oxygen Profiles with Expanded Urine Culture Bacterial Growth in Women
Time Frame: 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.
The study completion is expected at 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

Alan J. Wolfe

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Actual)

August 17, 2017

Study Completion (Actual)

August 17, 2017

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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