Clinical trial NCT02751073: Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy
Official title: Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Hysterectomy
Urinary Tract Infection
Keywords: Microbiota
Proteome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women undergoing pelvic reconstructive surgery for pelvic organ prolapse.

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.

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.

Eligibility 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

Primary outcomes:
measure: Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: 1 day (Pre-operative Urogynecology surgical consultation visit)
measure: Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: 1 day (Pre-operative Urogynecology surgical consultation visit)
measure: Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
measure: Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
measure: Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: Within 6 hours of collecting the pre-operative sample
measure: Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: Within 6 hours of collecting the pre-operative sample
measure: Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: 12-18 hours after surgery
measure: Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
timeFrame: 12-18 hours after surgery
measure: Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
timeFrame: Within the first 6 weeks after surgery
measure: Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
timeFrame: Within the first 6 weeks after surgery
measure: 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
timeFrame: Within the first 6 weeks after surgery
measure: Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
timeFrame: 6 weeks (up to 8 weeks)
measure: Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
timeFrame: 6 weeks (up to 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John A Occhino, M.D.
role: PRINCIPAL_INVESTIGATOR
References: