Clinical research landscape and evidence gaps in Traditional Chinese Medicine for recurrent urinary tract infections: a scoping review

Objective To map the clinical research landscape of Traditional Chinese Medicine (TCM) for the prevention and treatment of recurrent urinary tract infections (rUTIs), identify major gaps in study design and reporting, and inform the design of future clinical research. Methods We conducted a scoping review in accordance with the PRISMA Extension for Scoping Reviews (PRISMA-ScR). On 1 May 2026, we searched PubMed, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature Database. The search covered records from database inception through 30 April 2026. Eligible reports were primary clinical studies evaluating botanical-drug preparations or other TCM-related interventions for rUTIs. We descriptively summarized study design, diagnostic criteria, interventions, outcome measures, follow-up, safety reporting, and selected methodological reporting features. For botanical interventions, we additionally mapped taxonomic identifiability and the reporting of composition, preparation or extraction, source or manufacturer, batch, and chemical characterization. The protocol was prospectively registered on the Open Science Framework (DOI: 10.17605/OSF.IO/BYNFM). Results We included 91 clinical studies published between 1996 and 2026, comprising 74 randomized controlled trials (81.3%), eight non-randomized controlled trials (8.8%), seven case series (7.7%), and two retrospective studies (2.2%). Eighty-seven studies were conducted in mainland China, with one study each conducted in the United Kingdom, Iran, Ukraine, and Germany. Eighteen different terms were used to describe rUTIs. Twenty-eight studies (30.8%) did not report explicit diagnostic criteria, and 11 (12.1%) included mixed populations with upper and lower urinary tract infections. Botanical-drug decoctions were the most common intervention form, occurring in 72 studies (79.1%), and treatment duration ranged from 1 to 24 weeks. Among the 89 studies involving botanical interventions, 73 contained at least one medicinal-drug term that could not be linked unambiguously to a single species, 10 provided insufficient compositional information for taxonomic assessment, and the reported components were taxonomically resolved in six studies. Recurrence-related outcomes were reported in 48 studies (52.7%), whereas safety information was not reported in 60 studies (65.9%). Blinding was reported in eight studies (8.8%), and ethical approval was reported in 23 (25.3%). TCM syndrome differentiation was reported in 38 studies (41.8%), with considerable variation in the diagnostic standards used. Conclusion Clinical research on TCM for rUTIs has expanded, but cumulative evidence development remains constrained by interconnected inconsistencies in population definition, intervention characterization, recurrence and safety assessment, and methodological reporting. More complete methodological reporting co-occurred with broader and more clinically informative outcome assessment, suggesting that reporting standards and outcome-set development should be advanced together. Standardized rUTI definitions, a core outcome set centred on recurrence and safety, and integration of reproducible TCM syndrome criteria with clinically relevant biomedical phenotypes are priorities for building a more interpretable and internationally comparable evidence base. Clinical Trial Registration https://doi.org/10.17605/OSF.IO/BYNFM , identifier 10.17605/OSF.IO/BYNFM.