Bladder Environment: Microbiome Oxygen Relationship

Urinary Incontinence Clinical Trial

— BEMOR  

Official title:

Bladder Environment: Microbiome Oxygen Relationship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868463
• Other study ID #: 208221
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: February 19, 2018
• Start date: June 2, 2016
• Est. completion date: August 17, 2017

Study information

• Verified date: February 2018
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• UTI's

Locations

Country	Name	City	State
United States	Loyola University Health System	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Alan J. Wolfe

Country where clinical trial is conducted

United States, 

References & Publications (4)

Brubaker L, Nager CW, Richter HE, Visco A, Nygaard I, Barber MD, Schaffer J, Meikle S, Wallace D, Shibata N, Wolfe AJ. Urinary bacteria in adult women with urgency urinary incontinence. Int Urogynecol J. 2014 Sep;25(9):1179-84. doi: 10.1007/s00192-013-2325-2. Epub 2014 Feb 11. — View Citation

Brubaker L, Wolfe AJ. The new world of the urinary microbiota in women. Am J Obstet Gynecol. 2015 Nov;213(5):644-9. doi: 10.1016/j.ajog.2015.05.032. Epub 2015 May 21. — View Citation

Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. MBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14. — View Citation

Pearce MM, Zilliox MJ, Rosenfeld AB, Thomas-White KJ, Richter HE, Nager CW, Visco AG, Nygaard IE, Barber MD, Schaffer J, Moalli P, Sung VW, Smith AL, Rogers R, Nolen TL, Wallace D, Meikle SF, Gai X, Wolfe AJ, Brubaker L; Pelvic Floor Disorders Network. The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol. 2015 Sep;213(3):347.e1-11. doi: 10.1016/j.ajog.2015.07.009. Epub 2015 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Tension Measurement of Bladder Urine and Correlation of These Oxygen Profiles with Expanded Urine Culture Bacterial Growth in Women	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.