Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Mannose
- Conditions
- Urinary Tract Infections
- Sponsor
- Kantonsspital Aarau
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Frequency of UTIs
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Gloria Ryu
Assistant medical director
Kantonsspital Aarau
Eligibility Criteria
Inclusion Criteria
- •≥ 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
Arms & Interventions
mannose
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
Intervention: Mannose
placebo
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
Intervention: Lactose
Outcomes
Primary Outcomes
Frequency of UTIs
Time Frame: 6 months
Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.
Secondary Outcomes
- During UTI: Dysuria(during every UTI in the 6 months period)
- During UTI: Frequency(during every UTI in the 6 months period)
- During UTI: Flank (side) pain(during every UTI in the 6 months period)
- During UTI: Urgency(during every UTI in the 6 months period)
- During UTI: Cystalgia(during every UTI in the 6 months period)
- During UTI: Back pain(during every UTI in the 6 months period)