DOI: 10.1001/jamainternmed.2024.0264
Gail Hayward 1, Sam Mort1, Alastair D Hay 2, Michael Moore 3 , Nicholas P B Thomas4 5, Johanna Cook 1 , Jared Robinson 1 , Nicola Williams 1, Nicola Maeder1, Rebecca Edeson1, Marloes Franssen6, Jenna Grabey1, Margaret Glogowska1, Yaling Yang1, Julie Allen1, Christopher C Butler1
- 1Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, England, United Kingdom.
- 2Centre for Academic Primary Care, NIHR School for Primary Care Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, England, United Kingdom.
- 3Primary Care Research Centre, Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, England, United Kingdom.
- 4Windrush Medical Practice, Witney, England, United Kingdom.
- 5NIHR Clinical Research Network Thames Valley and South Midlands, Oxford, England, United Kingdom.
- 6Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, England, United Kingdom.
Abstract
Importance: Recurrent urinary tract infection (UTI) is a common debilitating condition in women, with limited prophylactic options. d-Mannose has shown promise in trials based in secondary care, but effectiveness in placebo-controlled studies and community settings has not been established.
Objective: To determine whether d-mannose taken for 6 months reduces the proportion of women with recurrent UTI experiencing a medically attended UTI.
Design, setting, and participants: This 2-group, double-blind randomized placebo-controlled trial took place across 99 primary care centers in the UK. Participants were recruited between March 28, 2019, and January 31, 2020, with 6 months of follow-up. Participants were female, 18 years or older, living in the community, and had evidence in their primary care record of consultations for at least 2 UTIs in the preceding 6 months or 3 UTIs in 12 months. Invitation to participate was made by their primary care center. A total of 7591 participants were approached, 830 responded, and 232 were ineligible or did not proceed to randomization. Statistical analysis was reported in December 2022.
Intervention: Two grams daily of d-mannose powder or matched volume of placebo powder.
Main outcomes and measures: The primary outcome measure was the proportion of women experiencing at least 1 further episode of clinically suspected UTI for which they contacted ambulatory care within 6 months of study entry. Secondary outcomes included symptom duration, antibiotic use, time to next medically attended UTI, number of suspected UTIs, and UTI-related hospital admissions.
Results: Of 598 women eligible (mean [range] age, 58 [18-93] years), 303 were randomized to d-mannose (50.7%) and 295 to placebo (49.3%). Primary outcome data were available for 583 participants (97.5%). The proportion contacting ambulatory care with a clinically suspected UTI was 150 of 294 (51.0%) in the d-mannose group and 161 of 289 (55.7%) in the placebo group (risk difference, -5%; 95% CI, -13% to 3%; P = .26). Estimates were similar in per protocol analyses, imputation analyses, and preplanned subgroups. There were no statistically significant differences in any secondary outcome measures.
Conclusions and relevance: In this randomized clinical trial, daily d-mannose did not reduce the proportion of women with recurrent UTI in primary care who experienced a subsequent clinically suspected UTI. d-Mannose should not be recommended for prophylaxis in this patient group.