Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections

Study Overview
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Brief Summary
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To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI)

Detailed Description
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Once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups: Group A: Patients with repeat UTIs who will receive prophylactic treatment for 6 Months. Group B: Patients with repeat UTIs who will receive prophylactic treatment for 3 Months. Control group: Patients with recurrent UTIs who will not receive as prophylactic treatment the supplement under study. The three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.

Official Title
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Randomised, Open-label, Controlled Clinical Trial to Evaluate the Efficacy of a Product Consisting of D Mannose 2 g+ Cran-max 500 mg+ Vitamin D3 0.001 mg (UROMANNOSA®) in Women With Recurrent Lower Urinary Tract Infections

Conditions
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Lower Urinary Tract Infection

Intervention / Treatment
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* Dietary Supplement: Group (A)
* Dietary Supplement: Group (B)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of Recurrent Lower Urinary Tract Infection (at least two episodes in the last 6 months or three episodes in the last 12 months). Multiple infections must be spaced a minimum of 2 weeks apart or if less, with a negative urine culture in between. Women who agree to participate and give their informed consent in writing Exclusion Criteria: Use of antibiotics or cranberry or other preventive treatment, pharmacological or not, for recurrence of urinary tract infections in the last two weeks. Patient with indwelling catheter or intermittent catheterization. Patients who present: Interstitial Cystitis, Neurogenic Bladder, Diabetes Mellitus, Nephrolithiasis, Cervical-Uterine Cancer diagnosed and treated less than 5 years ago. Use of anticoagulants or contraceptive methods using spermicides or diaphragms. Women consuming probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V.angustifolium (wild or lowbush blueberry), V. corymbosum ( highbush blueberry) or V. vitis-ideae (mountain blueberry), during the two weeks prior to recruitment. High consumption of fruits rich in phenolic compounds, with special reference to berries. Women allergic to berries Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group (C)<br>Control | |
| Experimental: Group (A)<br>Treatment | Dietary Supplement: Group (A)<br>* Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 6 months<br>|
| Experimental: Group (B)<br>Treatment | Dietary Supplement: Group (B)<br>* Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI Recurrence | Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months. | Through study completion, an average of one year | 
| UTI Recurrence | Time (in days) from the start of treatment to the next episode of UTI | Variable for each participant over course of up to one year | 
| Number of symptomatic UTIs |  | Variable for each participant over course of up to one year |