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

Recurrent Urinary Tract Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444975
• Other study ID #: NU369
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: September 5, 2016
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

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
• No intervention
No intervention

Locations

Country	Name	City	State
Bulgaria	Mc "Comac Medical"	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of UTI	Difference between groups in term of UTI recurrence over 12 months of study intervention	12 months	No