Preventing Recurrent Urinary Tract Infections With α-D-mannose

Study Overview
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Brief Summary
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In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo. The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo. H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo. H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.

Official Title
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Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Mannose
* Drug: Lactose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months; Laboratory urine culture: <103 CFUs Age > 18 years Exclusion Criteria: UTIs ≥ 12 within 1 year Pregnancy or Lactation Immune disease Lactose intolerance Urinary tract anomaly Systemic infection Newly started hormone therapy within the last 6 months Antibiotic prophylaxis within the last 6 months α-D-mannose intake within the last month Use of catheters Diabetes mellitus Participation to other studies

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mannose<br>2g d-mannose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months.The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary | Drug: Mannose<br>* The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.<br>* Other names: D-Mannose Oral Powder;|
| Placebo Comparator: placebo<br>2g Hänseler lactose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months. The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary | Drug: Lactose<br>* The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.<br>* Other names: Lactose powder;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of UTIs | Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During UTI: Dysuria | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period | 
| During UTI: Urgency | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period | 
| During UTI: Frequency | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period | 
| During UTI: Flank (side) pain | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period | 
| During UTI: Cystalgia | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period | 
| During UTI: Back pain | 4 categories: no, mild, moderate, severe | during every UTI in the 6 months period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D-mannose