Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections: TAPER (Techniques of APplying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Percentage of participants who are UTI-free at 6 months
研究概览
简要总结
Due to rising antibiotic resistance, there has been a focus on non-antibiotic prophylactic measures for postmenopausal patients with recurrent urinary tract infections (rUTI), one of which is the safe and efficacious option of vaginal estrogen therapy. Standard application of vaginal estrogen cream entails intravaginal application of the cream twice a week, but some providers counsel patients with rUTI to apply a small, pea-sized amount to the periurethral area. This ideally reduces the amount of vaginal estrogen used while attaining a similar effect. However, to date, there is no data to prove that the periurethral technique of application is similar or non-inferior to intravaginal application in preventing UTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Postmenopausal (definition: No menses for 1 or more years or surgical menopause (bilateral oophorectomy). If there is a past history of hysterectomy, patient must be age 56 or older (95th percentile for age at menopause) or have laboratory evidence of menopause (ie. FSH >30))
- •Meets criteria for recurrent urinary tract infections (UTIs) with 2 or more UTI in 6 months or 3 or more UTI in 1 year
- •May include patients who used vaginal estrogen previously if they have stopped use for 3 or more months prior to inclusion into study.
- •Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI
排除标准
- •Current use of vaginal or oral estrogen products
- •Inability or refusal to use vaginal estrogen
- •Daily antibiotic use
- •Significant vaginal stenosis (eg. due to lichen sclerosis, radiation or obliterative prolapse surgery) that would prohibit use of a vaginal applicator (ie. genital hiatus <1cm)
- •Inability to use vaginal applicator and without caregiver who can administer (eg. provider-managed pessary use, significant arthritis)
- •Frequent (1x weekly or more frequent) use of bladder instillations containing an antibiotic
- •Known hydronephrosis as a result of incomplete bladder emptying
- •Use of intermittent or indwelling urinary catheterization
- •Known bladder stones, mesh erosion into bladder, or foreign object in bladder
- •Unable to consent for self
- •Active treatment for an estrogen-dependent malignancy
研究组 & 干预措施
Intravaginal Estrogen Application
Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months
干预措施: Intravaginal application of estradiol cream (Drug)
Periurethral Estrogen Application
Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months
干预措施: Periurethral application of estradiol cream (Drug)
结局指标
主要结局
Percentage of participants who are UTI-free at 6 months
时间窗: 6 months
次要结局
- Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months(Baseline, 6 months)
- Change from baseline in vaginal symptoms at 6 months(Baseline, 6 months)
- Participant experience with use of estrogen cream(6 months)
- Change from baseline in urinary symptoms at 6 months(Baseline, 6 months)
- Change from baseline in sexual function at 6 months(Baseline, 6 months)
- Amount of estrogen cream used(6 months)
- Change from baseline in vaginal pH at 6 months(Baseline, 6 months)
- Change from baseline in vaginal maturation index at 6 months(Baseline, 6 months)
- Change from baseline in Vaginal and urinary E. coli levels at 6 months(Baseline, 6 months)
研究者
Stephanie Wang Zuo
Adjunct Professor
University of Pittsburgh