The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent Urinary Tract Infection
- Sponsor
- Danone Research
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Incidence of UTI
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of UTI
Time Frame: 12 months
Difference between groups in term of UTI recurrence over 12 months of study intervention