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OpenTrials
Completed

NCT Number: NCT02444975

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mc "Comac Medical"

Sofia, 1612, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mineral water

Dietary Supplement

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

Other names: Evian mineral water

Coaching program

Other

Coaching program to support increased water intake

No intervention

Other

No intervention

Primary outcomes

  1. Incidence of UTI

    Time frame: 12 months

    Difference between groups in term of UTI recurrence over 12 months of study intervention

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Acronym: S-HYDRACYST

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 15, 2015
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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