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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02751073
• Date of registration: 22/02/2016
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy
• Scientific title: Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection
• Date of first enrolment: February 2016
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02751073
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: John A Occhino, M.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary Tract Infection

Hysterectomy

Pelvic Organ Prolapse

Primary Outcome(s)

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

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]

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)]

Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing [Time Frame: 1 day (Pre-operative Urogynecology surgical consultation visit)]

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]

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)]

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

Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing [Time Frame: 1 day (Pre-operative Urogynecology surgical consultation visit)]

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)]

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]

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]

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]

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)]

Secondary ID(s)

15-006300

Source(s) of Monetary Support

Please refer to primary and secondary sponsors