Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02444975
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2015-04-29
Brief Title:
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women S-HYDRACYST
Sponsor:
Danone Research
Organization:
Danone Research
Study Overview
Official Title:
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women S-HYDRACYST
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S-HYDRACYST
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 15 L fluids per day urinary volume 12 L per day since they are most likely to have a predisposition to UTIs due to infrequent voiding
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 15 L fluids per day urinary volume 12 L per day since they are most likely to have a predisposition to UTIs due to infrequent voiding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None