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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-07-31

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.

Conditions

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Recurrent Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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

Group Type EXPERIMENTAL

Mineral water

Intervention Type DIETARY_SUPPLEMENT

1.5L/day of water on top of the normal fluid intake for 1 year

Coaching program

Intervention Type OTHER

Coaching program to support increased water intake

No intervention

No intervention

Group Type OTHER

No intervention

Intervention Type OTHER

No intervention

Interventions

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Mineral water

1.5L/day of water on top of the normal fluid intake for 1 year

Intervention Type DIETARY_SUPPLEMENT

Coaching program

Coaching program to support increased water intake

Intervention Type OTHER

No intervention

No intervention

Intervention Type OTHER

Other Intervention Names

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Evian mineral water

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mc "Comac Medical"

Sofia, , Bulgaria

Site Status

Countries

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Bulgaria

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.

Reference Type DERIVED
PMID: 30285042 (View on PubMed)

Other Identifiers

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NU369

Identifier Type: -

Identifier Source: org_study_id

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