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

Not Applicable

Completed

• Conditions: Recurrent Urinary Tract Infection
• Interventions: Dietary Supplement: Mineral water; Other: No intervention; Other: Coaching program

• Registration Number: NCT02444975
• Lead Sponsor: Danone Research

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Increased water intake+coaching program	Coaching program	Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
Increased water intake+coaching program	Mineral water	Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day
No intervention	No intervention	No intervention

Primary Outcome Measures

Name	Time	Method
Incidence of UTI	12 months	Difference between groups in term of UTI recurrence over 12 months of study intervention

Trial Locations

Locations (1)

Mc "Comac Medical"; 🇧🇬 Sofia, Bulgaria