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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02444975
Acronym
S-HYDRACYST
Enrollment
140
Registered
2015-05-15
Start date
2013-12-31
Completion date
2016-07-31
Last updated
2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Urinary Tract Infection

Keywords

Urinary Tract Infections, Water intake

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.

Interventions

DIETARY_SUPPLEMENTMineral water

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

Coaching program to support increased water intake

OTHERNo intervention

No intervention

Sponsors

Danone Global Research & Innovation Center
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of UTI12 monthsDifference between groups in term of UTI recurrence over 12 months of study intervention

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026