Status:
COMPLETED
Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Lead Sponsor:
Mayo Clinic
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Randomized controlled trial to determine clinical and microbiome difference between fractional CO2 Laser and vaginal estrogen in treating patients with recurrent urinary tract infection (UTI).
Detailed Description
Recurrent urinary tract infection (rUTI) is common in postmenopausal women and can lead to significant bothersome symptoms. This clinical scenario is a difficult and common clinical problem seen by th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04301934
Start Date
June 1 2020
End Date
April 30 2023
Last Update
March 26 2024
Active Locations (1)
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1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054