Trials / Completed
CompletedNCT02444975
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Danone Global Research & Innovation Center · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Mineral water | 1.5L/day of water on top of the normal fluid intake for 1 year |
| OTHER | Coaching program | Coaching program to support increased water intake |
| OTHER | No intervention | No intervention |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2015-05-15
- Last updated
- 2016-09-07
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT02444975. Inclusion in this directory is not an endorsement.