Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04301934

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Device: Mona Lisa Touch Drug: Conjugated estrogen Drug: Estradiol	N/A

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.

Primary Outcome: Improvement in recurrence of culture positive UTI

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.
Measurement 1: MESA and DIVA surveys of symptoms
Measurement 2: Observations of vaginal biopsy between.

Menopausal women will be recruited if subjects have recurrent UTI defined as 3 culture positive UTIs in 1 year or 2 culture positive UTIs in 6 months. Subjects will be randomized to standard of care with topical vaginal estrogen or 3 treatments of fractional CO2 LASER of the vagina. Samples will be collected to show microbiome and histologic changes with treatment.

Samples include:

Vaginal culture Urine culture vaginal biopsy (optional).

Validated questionnaires and clinical recurrence of UTI will also be gathered over 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Conjugated estrogen Current standard treatment for recurrent UTIs in postmenopausal women Other Names: Premarin Drug: Estradiol Current standard treatment for recurrent UTIs in postmenopausal women Other Names: Estrace
Experimental: Laser Therapy Group Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart.	Device: Mona Lisa Touch Fractional CO2 LASER

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Conjugated estrogen

Current standard treatment for recurrent UTIs in postmenopausal women

Other Names:

Premarin

Drug: Estradiol

Current standard treatment for recurrent UTIs in postmenopausal women

Other Names:

Estrace

Experimental: Laser Therapy Group

Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart.

Device: Mona Lisa Touch

Fractional CO2 LASER

Outcome Measures

Primary Outcome Measures

Improvement in recurrence of culture positive urinary tract infections [6 months]
Number of culture positive, symptomatic urinary tract infections in women

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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