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Completed

NCT Number: NCT02751073

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hysterectomy Infections Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 26, 2016
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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