- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02751073
Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy
August 14, 2018 updated by: John A. Occhino, Mayo Clinic
Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection
The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder.
The investigators are doing this research study to understand the relationship between microbes (the microbiome) and the occurrence of urinary tract infection following surgical removal of the uterus and pelvic organ prolapse repair.
The investigators expect Lactobacillus and Gardnerella will be the dominant organisms for most women.
Non-Lactobacillus dominant microbiome communities will be more common in women who ultimately develop postoperative urinary tract infection.
Study Overview
Status
Completed
Detailed Description
The goal of this pilot study is to characterize the presence and stability of the microbial community in the vagina and lower urinary tract in a cohort of 20 postmenopausal women undergoing transvaginal hysterectomy with pelvic reconstruction for pelvic organ prolapse.
The investigators intend to collect longitudinal samples in the preoperative, intraoperative, and postoperative time period in order to understand the pervasiveness of the microbes in the vagina and lower urinary tract, and to identify, in a very preliminary way, particular microbes that may be associated with postoperative urinary tract infection.
Study Type
Observational
Enrollment (Actual)
25
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
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Postmenopausal women undergoing pelvic reconstructive surgery for pelvic organ prolapse.
Description
Inclusion Criteria:
- Postmenopausal females (defined by cessation of menses for one full year)
- Planned surgical correction of pelvic organ prolapse with transvaginal hysterectomy and concomitant pelvic reconstruction for uterovaginal prolapse
- Scheduled surgery date within 4 weeks of study consent
- Physically able to self-collect vaginal swabs and clean-catch urine samples
Exclusion Criteria:
- Women who are premenopausal, pregnant or nursing
- Currently taking or have taken antibiotics in the past 2 weeks
- History of recurrent urinary tract infections
- History of mesh complications, including erosion/extrusion
- Non-vaginal approach to hysterectomy or prolapse repair
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: 1 day (Pre-operative Urogynecology surgical consultation visit)
|
Vaginal swabs will be collected from participants at the surgical consultation visit.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
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1 day (Pre-operative Urogynecology surgical consultation visit)
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Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: 1 day (Pre-operative Urogynecology surgical consultation visit)
|
Urine sample will be collected from participants at the surgical consultation visit.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
|
1 day (Pre-operative Urogynecology surgical consultation visit)
|
Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
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Vaginal swabs will be collected from participants on the day of surgery, prior to entering the surgical suite.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
|
Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
|
Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
|
Urine sample will be collected from participants on the day of surgery, prior to entering the surgical suite.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
|
Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
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Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: Within 6 hours of collecting the pre-operative sample
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Vaginal swabs will be collected from participants at the end of the surgical procedure.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
|
Within 6 hours of collecting the pre-operative sample
|
Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: Within 6 hours of collecting the pre-operative sample
|
Urine sample will be collected from participants at the end of the surgical procedure.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
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Within 6 hours of collecting the pre-operative sample
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Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: 12-18 hours after surgery
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Vaginal swabs will be collected from participants the morning following surgery, after removal of the vaginal packing.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
|
12-18 hours after surgery
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Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Time Frame: 12-18 hours after surgery
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Urine sample will be collected from participants the morning following surgery, after removal of the vaginal packing.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
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12-18 hours after surgery
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Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
Time Frame: Within the first 6 weeks after surgery
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Vaginal swabs will be collected at the onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition in the vagina in the setting of urinary tract infection and compare to microbiome of vagina during the perioperative period.
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Within the first 6 weeks after surgery
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Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
Time Frame: Within the first 6 weeks after surgery
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Urine sample will be collected at the onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract in the setting of urinary tract infection and compare to microbiome of the urinary tract during the perioperative period.
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Within the first 6 weeks after surgery
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Identification of key biomarkers associated with risk of postoperative urinary tract infection through proteomic mass spectrometry analysis of vaginal swab collected in the setting of postoperative urinary tract infection
Time Frame: Within the first 6 weeks after surgery
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Vaginal swab collected at onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit.
Proteomic mass spectrometry analysis of vaginal swab will be conducted.
The investigators will use this proteomic information together with the microbial community identified with 16S rRNA to identify a transition point or key biomarkers associated with risk of postoperative urinary tract infection.
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Within the first 6 weeks after surgery
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Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
Time Frame: 6 weeks (up to 8 weeks)
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Vaginal swabs will be collected from participants at the Urogynecology post-surgical consultation.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
|
6 weeks (up to 8 weeks)
|
Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
Time Frame: 6 weeks (up to 8 weeks)
|
Urine sample will be collected from participants at the Urogynecology post-surgical consultation.
DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
|
6 weeks (up to 8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John A Occhino, M.D., Mayo Clinic
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
February 1, 2016
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
July 30, 2018
Study Registration Dates
First Submitted
February 22, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 26, 2016
Study Record Updates
Last Update Posted (Actual)
August 16, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-006300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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