Recurrent Urinary Tract InfectionS-HYDRACYSTNCT02444975
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
A study testing Mineral water and Coaching program in people with Recurrent Urinary Tract Infection, run by Danone Global Research & Innovation Center at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Mineral water and Coaching program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBulgaria
- Study dates
- Dec 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 3 clinical recurrences of symptomatic UTI in the last 12 months
- Age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Recurrent Urinary Tract Infection
- Being tested
- Mineral water, Coaching program, No intervention
- Keywords
- Urinary Tract Infections, Water intake
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral waterDietary supplement
Also called Evian mineral water
1.5L/day of water on top of the normal fluid intake for 1 year
Coaching programOther
Coaching program to support increased water intake
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Increased water intake+coaching program | Experimental | Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day Receives: Dietary Supplement: Mineral water; Other: Coaching program |
| No intervention | Other | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of UTI
Difference between groups in term of UTI recurrence over 12 months of study intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444975
- Sponsor's protocol ID
- NU369
- Acronym
- S-HYDRACYST
- Status last verified
- Sep 2016
- First submitted
- 29 Apr 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30285042
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
- ClinicalTrials.gov ID
- NCT02444975
- Acronym / sponsor ID
- S-HYDRACYST / NU369
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- Urinary Tract Infections, Water intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased water intake+coaching program | Experimental | Dietary Supplement: Mineral water, Other: Coaching programWomen in the intervention group will be asked to increase their mineral water intake of 1.5L/day |
| No intervention | Other | Other: No interventionNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 3 clinical recurrences of symptomatic UTI in the last 12 months
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral waterAlso: Evian mineral water1.5L/day of water on top of the normal fluid intake for 1 year | Dietary supplement | Increased water intake+coaching program |
| Coaching programCoaching program to support increased water intake | Other | Increased water intake+coaching program |
| No interventionNo intervention | Other | No intervention |
Primary outcome
Incidence of UTI
Time frame: 12 months
Difference between groups in term of UTI recurrence over 12 months of study intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 30285042Hooton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral water and Coaching program in people with Recurrent Urinary Tract Infection, run by Danone Global Research & Innovation Center at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of UTI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.