D-MannosE to prevent Recurrent urinary tract InfecTions (MERIT): protocol for a randomised controlled trial
Open Access
- 13 January 2021
- Vol. 11 (1), e037128
- https://doi.org/10.1136/bmjopen-2020-037128
Abstract
Introduction Recurrent urinary tract infections (RUTIs) have a significant negative impact on quality of life and healthcare costs. To date, daily prophylactic antibiotics are the only treatment which have been shown to help prevent RUTIs. D-mannose is a type of sugar which is believed to inhibit bacterial adherence to uroepithelial cells, and is already being used by some women in an attempt to prevent RUTIs. There is currently insufficient rigorous evidence on which to base decisions about its use. The D-mannose to prevent recurrent urinary tract infections (MERIT) study will evaluate whether D-mannose is clinically and cost-effective in reducing frequency of infection and symptom burden for women presenting to UK primary care with RUTI. Methods and analysis MERIT will be a two-arm, individually randomised, double blind placebo controlled, pragmatic trial. Participants will be randomised to take D-mannose powder or placebo powder daily for 6 months. The primary outcome will be the number of medical attendances attributable to symptoms of RUTI. With 508 participants we will have 90% power to detect a 50% reduction in the chance of a further clinically suspected UTI, assuming 20% lost to follow-up. Secondary outcomes will include: number of days of moderately bad symptoms of UTI; time to next consultation; number of clinically suspected UTIs; number of microbiologically proven UTIs; number of antibiotic courses for UTI; quality of life and healthcare utilisation related to UTI. A within trial economic evaluation will be conducted to examine cost-effectiveness of D-mannose in comparison with placebo. A nested qualitative study will explore participants’ experiences and perceptions of recruitment to, and participation in a study requiring a daily treatment. Ethics and dissemination Ethical approval has been obtained from South West-Central Bristol Research Ethics Committee. Publication of the MERIT study is anticipated to occur in 2021. Trial registration number ISRCTN 13283516.Keywords
Funding Information
- National Institute for Health Research (385)
This publication has 19 references indexed in Scilit:
- Mannose metabolism: More than meets the eyeBiochemical and Biophysical Research Communications, 2014
- How women manage recurrent urinary tract infections: an analysis of postings on a popular web forumBMC Family Practice, 2014
- d-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trialWorld Journal of Urology, 2013
- Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysisBMJ, 2010
- Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trialBMJ, 2010
- Receptor binding studies disclose a novel class of high‐affinity inhibitors of the Escherichia coli FimH adhesinMolecular Microbiology, 2004
- Antibiotics for preventing recurrent urinary tract infection in non-pregnant womenEmergencias, 2004
- Recurrent urinary tract infection in womenBMJ, 2003
- Effect of D-mannose and D-glucose on Escherichia coli bacteriuria in ratsUrological Research, 1983
- Long-Term Antimicrobial Prophylaxis for Recurrent Urinary Tract Infection in WomenClinical Infectious Diseases, 1982