N/A
Completed N=12
Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Source: ClinicalTrials.gov NCT04301934 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Mar 2024
Primary outcomePrimary: Prevalence of Urinary Tract Infections (UTI) — 28.6; 60; 71.4; 40 percentage of subjects — p=0.034
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Urinary Tract Infections (UTI) |
28.6; 60; 71.4; 40 | 0.034 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04301934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.