Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Prevalence of Urinary Tract Infections (UTI)
Study Overview
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 the urologist and urogynecologist with limited options for treatment. Overuse of antibiotics has led to significant resistant microorganisms and can have adverse side effects such as C. Dificile colitis. Current treatments include topical vaginal estrogen and prophylactic antibiotics. Other supplements such as cranberry pills, methenamine and D-mannose have varying levels of evidence and efficacy.
Fractional CO2 LASER vaginal therapy has recently been studied for the treatment of GSM. LASER therapy is currently commercially available and has FDA clearance for use in gynecology. Current evidence shows that with treatment, histologic changes of the vaginal epithelium have shown regeneration to a premenopausal state, along with subjective improvement in GSM symptoms and sexual function. Recent literature has shown improvements in thickening of vaginal epithelium, decreased vaginal pH and improvement in the vaginal microbiome. Based on this, the investigators propose fractional CO2 laser may have a positive impact on women with rUTI.
- The investigators therefore hypothesize that fractional CO2 LASER vaginal therapy is non-inferior to topical vaginal estrogen therapy for the treatment of rUTI.
a. Primary Outcome: Improvement in recurrence of culture positive UTI 2. The investigators also hypothesize that LASER therapy will improve the urinary and vaginal microbiome, decreasing the uropathogenic presence and increasing Lactobacillus.
- Measurement 1: The number of UTI with UPEC isolated from patients
- Measurement 2: The pH of the vagina as a proxy for presence of Lactobacillus sp.
- Measurement 3: Categorize vaginal and urinary microbial communities
- The investigators hypothesize that LASER therapy will improve symptoms of GSM and be associated with regenerative change in vaginal histology.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Vaginal Estrogen Therapy Group
Women randomized to vaginal estrogen therapy will be offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Intervention: Conjugated estrogen (Drug)
Vaginal Estrogen Therapy Group
Women randomized to vaginal estrogen therapy will be offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly
Intervention: Estradiol (Drug)
Laser Therapy Group
Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart.
Intervention: Mona Lisa Touch (Device)
Outcomes
Primary Outcomes
Prevalence of Urinary Tract Infections (UTI)
Time Frame: 4 months
Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.
Secondary Outcomes
No secondary outcomes reported
Investigators
Johnny Yi
Principal Investigator
Mayo Clinic