A Randomized Controlled Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections in Post-menopausal Women
University of Texas Southwestern Medical Center
Summary
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.
Description
The proposed study on D-mannose prophylaxis is designed to address a critical unmet medical need to improve the understanding and prevention of rUTI (recurrent urinary tract infection) in post-menopausal women, a population disproportionately affected by rUTI and understudied. The efficacy of D-mannose on preventing uncomplicated rUTI will be elucidated, and additional study measures (including urine culture and one-hour D-mannose test results) may help establish an ideal candidate for responding to daily D-mannose intake over time. The proposed study will follow CONSORT guidelines for randomi…
Eligibility
- Age range
- 55–85 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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. * A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than stage 2), measurement of post-void…
Interventions
- Dietary SupplementD-Mannose
D-mannose (2g, i.e., 4 x 500mg capsules) daily for 12 months.
- Dietary SupplementPlacebo
Placebo daily for 12 months.
Location
- University of Texas Southwestern Medical CenterDallas, Texas