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Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy

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ClinicalTrials.gov Identifier: NCT02751073
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
John A. Occhino, Mayo Clinic

Brief Summary:
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.

Condition or disease
Pelvic Organ Prolapse Hysterectomy Urinary Tract Infection

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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection
Study Start Date : February 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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) ]
    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.

  4. 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.

  5. 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 ]
    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.

  6. 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.

  7. Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing [ Time Frame: 12-18 hours after surgery ]
    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.

  8. Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing [ Time Frame: 12-18 hours after surgery ]
    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.

  9. 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 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. 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) ]
    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.

  13. 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.


Biospecimen Retention:   Samples With DNA
Vaginal swabs and urine samples (catheterized and clean-catch) collected longitudinally throughout the perioperative period.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal women undergoing pelvic reconstructive surgery for pelvic organ prolapse.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751073


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: John A Occhino, M.D. Mayo Clinic

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Responsible Party: John A. Occhino, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02751073     History of Changes
Other Study ID Numbers: 15-006300
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John A. Occhino, Mayo Clinic:
Microbiota
Proteome

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urologic Diseases