A Study to Evaluate Feasibility of Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Overview
Tab Title Description
Study type
InterventionalDescribes 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
- Jacksonville, Florida: 18-002297
- Scottsdale/Phoenix, Arizona: 18-002297
NCT ID: NCT04301934
Sponsor Protocol Number: 18-002297
About this study
The purpose of this study is to evaluate the clinical difference between the LASER and topical vaginal estrogen in treating patients with recurrent urinary tract infections (rUTI).
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:
- Female patient > 18 years old.
- Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses >12 months.
- Recurrent urinary tract infections as defined by 3 culture positive urine cultures in the last 12 months, or 2 positive urine cultures in the last 6 months.
- Positive urine cultures defined by > 100K colony forming units of 1 or 2 bacterial species on clean catch sample, or > 1000 colony forming units of 1 or 2 bacterial species on sample via straight catheterization.
- Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.
Exclusion Criteria:
- Hematuria without appropriate workup.
- Pelvic organ prolapse at or beyond the hymen.
- Clinically relevant urinary retention.
- Pelvic reconstructive surgery within 6 months.
- Prior synthetic mesh procedure for pelvic organ. prolapse or urinary incontinence.
- Clinically relevant nephrolithiasis.
- History of breast cancer.
- 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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Anita Chen, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Johnny Yi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available