Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Prevalence of Urinary Tract Infections (UTI)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: 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
干预措施: Estradiol (Drug)
Laser Therapy Group
Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart.
干预措施: Mona Lisa Touch (Device)
结局指标
主要结局
Prevalence of Urinary Tract Infections (UTI)
时间窗: 4 months
Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.
次要结局
未报告次要终点