The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
NCT ID: NCT02444975
Last Updated: 2016-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2013-12-31
2016-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Increased water intake+coaching program
Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
Mineral water
1.5L/day of water on top of the normal fluid intake for 1 year
Coaching program
Coaching program to support increased water intake
No intervention
No intervention
No intervention
No intervention
Interventions
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Mineral water
1.5L/day of water on top of the normal fluid intake for 1 year
Coaching program
Coaching program to support increased water intake
No intervention
No intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Danone Global Research & Innovation Center
INDUSTRY
Responsible Party
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Locations
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Mc "Comac Medical"
Sofia, , Bulgaria
Countries
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References
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Hooton TM, Vecchio M, Iroz A, Tack I, Dornic Q, Seksek I, Lotan Y. Effect of Increased Daily Water Intake in Premenopausal Women With Recurrent Urinary Tract Infections: A Randomized Clinical Trial. JAMA Intern Med. 2018 Nov 1;178(11):1509-1515. doi: 10.1001/jamainternmed.2018.4204.
Other Identifiers
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NU369
Identifier Type: -
Identifier Source: org_study_id
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