Back to resultsThe Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST (S-HYDRACYST)
Primary Purpose
Recurrent Urinary Tract Infection
Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Mineral water
Coaching program
No intervention
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Urinary Tract Infection focused on measuring Urinary Tract Infections, Water intake
Eligibility 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
Sites / Locations
- Mc "Comac Medical"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Increased water intake+coaching program
No intervention
Arm Description
Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
No intervention
Outcomes
Primary Outcome Measures
Incidence of UTI
Difference between groups in term of UTI recurrence over 12 months of study intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02444975
Brief Title
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
Acronym
S-HYDRACYST
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
Urinary Tract Infections, Water intake
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Increased water intake+coaching program
Arm Type
Experimental
Arm Description
Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
Arm Title
No intervention
Arm Type
Other
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Mineral water
Other Intervention Name(s)
Evian mineral water
Intervention Description
1.5L/day of water on top of the normal fluid intake for 1 year
Intervention Type
Other
Intervention Name(s)
Coaching program
Intervention Description
Coaching program to support increased water intake
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Incidence of UTI
Description
Difference between groups in term of UTI recurrence over 12 months of study intervention
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Mc "Comac Medical"
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
12. IPD Sharing Statement
Citations:
PubMed Identifier
30285042
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
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