Nuffield Department of Orthopaedics, Rheumathology and Musculoskeletal Sciences, University of Oxford, Oxford, Oxfordshire, UK.
Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, Oxfordshire, UK.
BMJ Open. 2021 Jan 13;11(1):e037128. doi: 10.1136/bmjopen-2020-037128.
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.
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.
Ethical approval has been obtained from South West-Central Bristol Research Ethics Committee. Publication of the MERIT study is anticipated to occur in 2021.
ISRCTN 13283516.
复发性尿路感染（RUTI）对生活质量和医疗保健成本有重大负面影响。迄今为止，唯一被证明有助于预防 RUTI 的治疗方法是每日预防性抗生素。D-甘露糖是一种据称可抑制细菌黏附在上皮细胞的糖，一些女性已在尝试使用它来预防 RUTI。目前尚无足够严格的证据来支持其使用的决策。D-甘露糖预防复发性尿路感染（MERIT）研究将评估 D-甘露糖在减少英国初级保健中出现 RUTI 的女性感染频率和症状负担方面是否具有临床和成本效益。
MERIT 将是一项两臂、个体随机、双盲、安慰剂对照、实用试验。参与者将被随机分配每天服用 D-甘露糖粉或安慰剂粉 6 个月。主要结局将是归因于 RUTI 症状的医疗就诊次数。如果有 508 名参与者，我们将有 90%的把握检测到进一步临床疑似尿路感染的机会减少 50%，假设 20%的参与者失访。次要结局包括：中度 UTI 症状的天数；下次就诊时间；临床疑似 UTI 的次数；微生物证实的 UTI 的次数；用于 UTI 的抗生素疗程数；与 UTI 相关的生活质量和医疗保健利用。将进行一项内试验经济评估，以检查 D-甘露糖与安慰剂相比的成本效益。一项嵌套定性研究将探索参与者对招募和参与需要每日治疗的研究的经验和看法。
已获得南威尔士-中布里斯托尔研究伦理委员会的伦理批准。预计 2021 年将发表 MERIT 研究结果。
ISRCTN 13283516。
