Bladder Environment: Microbiome Oxygen Relationship

Completed

• Conditions: Urinary Incontinence; UTI's

• Registration Number: NCT02868463
• Lead Sponsor: Loyola University

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.

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 Timeline

• Study Start: 2016-06-02
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Primary Completion: 2017-08-17
• Study Completion: 2017-08-17
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Loyola University Health System; 🇺🇸 Maywood, Illinois, United States