Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estrogens; Estrogens, Conjugated (USP); Polyestradiol phosphate

Criteria

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