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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751073
• Other study ID #: 15-006300
• Status: Completed
• Start date: February 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 30, 2018
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hysterectomy
• Infection
• Pelvic Organ Prolapse
• Prolapse
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing	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.	1 day (Pre-operative Urogynecology surgical consultation visit)
Primary	Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing	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)
Primary	Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing	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)
Primary	Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing	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)
Primary	Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing	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
Primary	Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing	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.	Within 6 hours of collecting the pre-operative sample
Primary	Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing	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
Primary	Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing	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.	12-18 hours after surgery
Primary	Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing	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.	Within the first 6 weeks after surgery
Primary	Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing	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.	Within the first 6 weeks after surgery
Primary	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	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.	Within the first 6 weeks after surgery
Primary	Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing	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)
Primary	Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing	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)