A Study to Evaluate the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After A Hysterectomy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006300
NCT ID: NCT02751073
Sponsor Protocol Number: 15-006300
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Occhino, M.D., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available