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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 (S-HYDRACYST)

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ClinicalTrials.gov Identifier: NCT02444975
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Dietary Supplement: Mineral water Other: Coaching program Other: No intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
Study Start Date : December 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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Arms and Interventions
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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 Name: Evian mineral water

Other: Coaching program
Coaching program to support increased water intake
No intervention
No intervention
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of UTI [ Time Frame: 12 months ]
    Difference between groups in term of UTI recurrence over 12 months of study intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444975


Locations
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Bulgaria
Mc "Comac Medical"
Sofia, Bulgaria, 1612
Sponsors and Collaborators
Danone Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT02444975    
Other Study ID Numbers: NU369
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Keywords provided by Danone Research:
Urinary Tract Infections
Water intake
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases