The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST

Conditions
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Recurrent Urinary Tract Infection

Intervention / Treatment
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* Dietary Supplement: Mineral water
* Other: Coaching program
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 3 clinical recurrences of symptomatic UTI in the last 12 months Age ≥ 18 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased water intake+coaching program<br>Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day | Dietary Supplement: Mineral water<br>* 1.5L/day of water on top of the normal fluid intake for 1 year<br>* Other names: Evian mineral water;Other: Coaching program<br>* Coaching program to support increased water intake<br>|
| Other: No intervention<br>No intervention | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of UTI | Difference between groups in term of UTI recurrence over 12 months of study intervention | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Tract Infections, Water intake