The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of UTI
研究概览
简要总结
The purpose of this study is to determine whether increased water intake is effective in preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women suffering from UTI recurrences.
详细描述
This study aims to assess the effect of increased daily water intake on the frequency of clinical, recurrent urinary tract infections (UTI) among low drinking pre-menopausal women suffering from recurrent community-acquired UTI over 12 consecutive months of study product consumption. It is a prospective, single site, open-label, randomised controlled trial in two parallel groups:
- Control group: not changing their fluid intake habits
- Intervention group: provided with mineral water, fluid intake recommendations and regular hydration coaching support
The study population consists in pre-menopausal women diagnosed with recurrent UTIs and having a 'low drinker' profile.
The total number of randomized subjects in this study is estimated at 140. The study will include only women who are low-drinkers (< 1.5 L fluids per day; urinary volume < 1.2 L per day) since they are most likely to have a predisposition to UTIs due to infrequent voiding.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 3 clinical recurrences of symptomatic UTI in the last 12 months
- •Age ≥ 18 years
排除标准
- •Incapacity / non-willingness to consume 1.5 L of drinking water per day on top of their usual consumption
- •Women with history of UTI complications (pyelonephritis or other) in the last 12 months
- •Subjects with interstitial cystitis
- •Subjects with severe or uncontrolled organic disease, likely to interfere with the parameters of the study
研究组 & 干预措施
Increased water intake+coaching program
Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
干预措施: Mineral water (Dietary Supplement)
Increased water intake+coaching program
Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
干预措施: Coaching program (Other)
No intervention
No intervention
干预措施: No intervention (Other)
结局指标
主要结局
Incidence of UTI
时间窗: 12 months
Difference between groups in term of UTI recurrence over 12 months of study intervention
次要结局
未报告次要终点