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

September 5, 2016 updated by: Danone Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1612
        • Mc "Comac Medical"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Increased water intake+coaching program
Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
Dietary supplement: Mineral water
1.5L/day of water on top of the normal fluid intake for 1 year
Other Names:
  • Evian mineral water
Other: Coaching program
Coaching program to support increased water intake
Other: No intervention
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of UTI
Time Frame: 12 months
Difference between groups in term of UTI recurrence over 12 months of study intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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