A Study to Analyze the Vaginal and Bladder Microbiome in Patients Undergoing Vaginal Estrogen or Vaginal LASER Therapy
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
- Scottsdale/Phoenix, Arizona: 19-006447
Sponsor Protocol Number: 19-006447
About this study
The purpose of this study is to evaluate vaginal microbiome at baseline and at 3 months in menopausal women with either vaginal atrophy (with or without rUTI) or rUTI, following treatment of vaginal estrogen and LASER therapy, to evaluate the bladder microbiome at baseline and at 3 months in menopausal women with vaginal atrophy with rUTI undergoing treatment of vaginal estrogen or LASER therapy, and to compare the microbial communities between women who undergo vaginal estrogen with those who undergo LASER therapy.
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:
- Planned treatment of either vaginal estrogen and/or vaginal LASER therapy.
- Female patient >18 years old.
- Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses > 12 months.
- Clinical diagnosis of vaginal atrophy with or without rUTI or recurrent UTI.
Exclusion Criteria:
- Hematuria without appropriate workup.
- Pelvic organ prolapse at or beyond the hymen.
- Pelvic reconstructive surgery within 6 months.
- Clinically relevant nephrolithiasis.
- History of breast cancer will be excluded in the topical estrogen arm but can be included in the vaginal laser arm.
- Contraindication to topical estrogen therapy.
- Anticoagulation therapy.
- Prior pelvic or vaginal radiation therapy.
- Prior gynecologic malignancy.
- Undiagnosed genital bleeding.
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Johnny Yi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available