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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Increased water intake+coaching program | Experimental | Women in the intervention group will be asked to increase their mineral water intake of 1.5L/day |
|
| No intervention | Other | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mineral water | Dietary Supplement | 1.5L/day of water on top of the normal fluid intake for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of UTI | Difference between groups in term of UTI recurrence over 12 months of study intervention | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mc "Comac Medical" | Sofia | 1612 | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30285042 | Derived | 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. |
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| Coaching program | Other | Coaching program to support increased water intake |
|
| No intervention | Other | No intervention |
|
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D008900 | Mineral Waters |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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