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Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04301934
Enrollment
12
Registered
2020-03-10
Start date
2020-06-01
Completion date
2023-04-30
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

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. 1. 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. 1. Measurement 1: The number of UTI with UPEC isolated from patients 2. Measurement 2: The pH of the vagina as a proxy for presence of Lactobacillus sp. 3. Measurement 3: Categorize vaginal and urinary microbial communities 3. The investigators hypothesize that LASER therapy will improve symptoms of GSM and be associated with regenerative change in vaginal histology. 1. Measurement 1: MESA and DIVA surveys of symptoms 2. 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.

Interventions

DEVICEMona Lisa Touch

Fractional CO2 LASER

Current standard treatment for recurrent UTIs in postmenopausal women

DRUGEstradiol

Current standard treatment for recurrent UTIs in postmenopausal women

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Urinary Tract Infections (UTI)4 monthsPrevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.

Countries

United States

Participant flow

Participants by arm

ArmCount
Vaginal Estrogen Therapy Group
Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly Conjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women Estradiol: Current standard treatment for recurrent UTIs in postmenopausal women
7
Laser Therapy Group
Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart. Mona Lisa Touch: Fractional CO2 LASER
5
Total12

Baseline characteristics

CharacteristicVaginal Estrogen Therapy GroupTotalLaser Therapy Group
Age, Continuous67.2 years
STANDARD_DEVIATION 6.41
68.0 years
STANDARD_DEVIATION 7.49
69.1 years
STANDARD_DEVIATION 9.47
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants12 Participants5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants10 Participants4 Participants
Region of Enrollment
United States
7 participants12 participants5 participants
Sex: Female, Male
Female
7 Participants12 Participants5 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 5
other
Total, other adverse events
3 / 73 / 5
serious
Total, serious adverse events
2 / 70 / 5

Outcome results

Primary

Prevalence of Urinary Tract Infections (UTI)

Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.

Time frame: 4 months

ArmMeasureGroupValue (NUMBER)
Vaginal Estrogen Therapy GroupPrevalence of Urinary Tract Infections (UTI)No UTI28.6 percentage of subjects
Vaginal Estrogen Therapy GroupPrevalence of Urinary Tract Infections (UTI)1 + UTI71.4 percentage of subjects
Laser Therapy GroupPrevalence of Urinary Tract Infections (UTI)No UTI60 percentage of subjects
Laser Therapy GroupPrevalence of Urinary Tract Infections (UTI)1 + UTI40 percentage of subjects
p-value: 0.034Farrington-Manning

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026