NCT02444975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

April 29, 2015

Last Update Submit

September 5, 2016

Conditions

Recurrent Urinary Tract Infection

Keywords

Urinary Tract InfectionsWater intake

Outcome Measures

Primary Outcomes (1)

  • Incidence of UTI

    Difference between groups in term of UTI recurrence over 12 months of study intervention

    12 months

Study Arms (2)

Increased water intake+coaching program

EXPERIMENTAL

Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day

Dietary Supplement: Mineral waterOther: Coaching program

No intervention

OTHER

No intervention

Other: No intervention

Interventions

Mineral waterDIETARY_SUPPLEMENT

1.5L/day of water on top of the normal fluid intake for 1 year

Also known as: Evian mineral water
Increased water intake+coaching program
Coaching programOTHER

Coaching program to support increased water intake

Increased water intake+coaching program
No interventionOTHER

No intervention

No intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 3 clinical recurrences of symptomatic UTI in the last 12 months
  • Age ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mc "Comac Medical"

Sofia, 1612, Bulgaria

Location

Related Publications (1)

  • 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.

    PMID: 30285042DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Mineral Waters

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 15, 2015

Study Start

December 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

BU(1)