Pilot Study: Effects of Flourish Vaginal Care System in Women With Recurrent Symptomatic Urinary Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- UTI recurrence
研究概览
简要总结
An over-the-counter vaginal care system is being tested to see if it may be effective in preventing recurrence of symptomatic urinary tract infection (UTI) in women who have had multiple UTIs within the past year.
详细描述
Women who have a urinary tract infection (UTI) may experience a recurrence within weeks or months of treatment. Some women may experience 8 or more UTIs in a single year, leading to multiple rounds of antibiotics, with the individual risks to organs and risk of antibiotic resistance growing with each round. Alternative methods for prevention of recurrent UTI is therefore desirable. This study will test whether women who use a commercially available, over-the-counter vaginal care system may be able to reduce recurrences of UTI over a six-month period. This is a pilot study designed to determine whether a larger randomized controlled trial in the future would be justified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal cis women aged 18-52 who are in generally good health
- •History of at least 2 UTIs in the past six months, or three prior UTIs in the past year, documented in the medical record. At least one must be culture-proven.
排除标准
- •Pregnant or trying to become pregnant
- •Immunosuppressed
- •Known allergies to aloe vera or to other components of Restore®, Balance or BiopHresh®
- •Known vaginal infection other than BV or yeast infection at time of screening
- •Women who have needed changes to medical intervention or in-office procedures in the last 3 months
- •Women using vaginal acidifying agents or spermicides for contraception
- •Women who wear a pessary
结局指标
主要结局
UTI recurrence
时间窗: Baseline to 6 months
Frequency of symptomatic UTI over study duration will be assessed (number of occurrences per person). UTI will be diagnosed when one or more symptoms is present (urinary urgency, frequency, sense of burning, pelvic pain, fever, flank pain) along with one or more confirming lab tests (positive culture, urine nitrites or leukocytes).
Vaginal Microbiome
时间窗: 3 months to 6 months
The vaginal microbiome will be assessed using next-generation sequencing (NGS) technology to assign the biome to one of 5 "community state types" (CST). The outcome will examine whether the vaginal microbiome changes from an unhealthy one (IV or III) to a healthy one (I, II, or V).
次要结局
- Vulvovaginal symptoms questionnaire (VSQ) + addendum(6 months)
- Vaginal pH(3 months to 6 months)
- Associations between microbes and UTI(Baseline to 6 months.)