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

Completed

Conditions studied: Pelvic Organ Prolapse, Hysterectomy, Urinary Tract Infection

In brief

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.

Key facts

Study ID

NCT02751073

Run by

Mayo Clinic

People needed

25

Starts

2016-02-01

Expected to finish

2018-07-30

Last updated by the study team

2018-08-16

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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