Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Completed · Not applicable

Conditions studied: Urinary Tract Infections

In brief

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).

Key facts

Study ID

NCT04301934

Run by

Mayo Clinic

People needed

12

Starts

2020-06-01

Expected to finish

2023-04-30

Last updated by the study team

2024-03-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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