NCT02868463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

August 4, 2016

Last Update Submit

February 19, 2018

Conditions

Urinary IncontinenceUTI's

Keywords

oxygen tensionFemale Urinary MicrobiomeUrinary Tract SymptomsUrine Oxygen Level

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female only participants are being studied

You may qualify if:

  • Age \> 18
  • No indwelling urethral catheter
  • At least 50 mL of urine in their bladder as determined by the clinic's bladder scanner

You may not qualify if:

  • Non-English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

Related Publications (4)

  • 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.

    PMID: 26003055BACKGROUND

  • 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.

    PMID: 26210757BACKGROUND

  • 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.

    PMID: 24515544BACKGROUND

  • 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.

    PMID: 25006228BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples will be frozen and stored in the event additional analysis is necessary

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth R Mueller, MD

    Loyola University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 16, 2016

Study Start

June 2, 2016

Primary Completion

August 17, 2017

Study Completion

August 17, 2017

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

US(1)