A randomized, double-blind, placebo-controlled, 12-month study to determine the effectiveness of D-mannose (2g daily) supplementation in rUTI (recurrent urinary tract infection) prevention in post-menopausal women.
Female, post-menopausal, age ≥ 55 years old
Diagnosis of recurrent UTI, defined as ≥ 3 symptomatic culture-proven UTI episodes in 12 months or ≥ 2 in 6 months.
Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire79 and negative urine culture (<103 colony forming units per ml of urine).
Able to attend all follow-up appointments for the study.
Current use of D-mannose. Patients willing to stop taking D-mannose will be offered to join the trial after a 4-week wash-out period.
Complicated UTIs, including need for catheter drainage or intermittent catheterization, neurogenic bladder, bladder augmentation, or urinary diversion.
Ongoing supplement use (Box 1). Patients willing to stop taking the listed supplements will be offered to join the trial after a 4-week wash-out period.
Evidence of upper tract infection (pyelonephritis), including temperature higher than 38°C, flank/lumbar pain or tenderness
Parallel
D-Mannose
Dietary supplementD-mannose (2g, i.e., 4 x 500mg capsules) daily for 12 months.
Placebo
Dietary supplementPlacebo daily for 12 months.
Failure rate
To determine whether prophylaxis with D-mannose reduces the incidence of UTI episodes compared to placebo. "Failure rate," defined as having 2 UTIs in 6 months or 3 in one year.
Number of UTI antibiotic treatments
To investigate if D-mannose reduces the need for antibiotic use due to recurrent UTIs (measured as number of antibiotic courses for symptomatic culture-proven UTI episodes) compared to placebo. Number of UTI antibiotic treatments during the 6 months of treatment. If the participant receives \>1 antibiotic course for UTI without symptom relief, it is regarded as one episode and counted as one antibiotic treatment. If there has been an asymptomatic period of at least 14 days in between two UTI antibiotic courses, this will be regarded as a new antibiotic treatment.
Symptom severity
To investigate if D-mannose reduces the severity of UTI symptoms compared to placebo. Record symptom severity using a validated UTI symptom assessment questionnaire.
Serious adverse events associated with D-mannose
To determine the frequency of serious adverse events associated with D-mannose. Number of participants who experienced adverse events \>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0.
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