Recurrent urinary tract infection (rUTI), defined as =2 episodes within 6 months or =3 episodes within 12 months, is among the most common infections worldwide. It can substantially impair patients' physical and mental quality of life, but also closely link to increased healthcare cost and the escalating crisis of antimicrobial resistance. Thus, rUTI has become a major global public health problem.
The management of rUTI involves two phazes: treatment of acute symptomatic episodes and long-term prevention of recurrence. Traditionally, antibiotic therapy has been the mainstay for both acute treatment and long-term prophylaxis. However, growing concern over the adverse effects of repeated antimicrobial exposures, particularly the emergence and spread of antibiotic resistance, has prompted a shift of focus toward novel non-antibiotic therapies such as non-antibiotic symptomatic therapies for acute episodes and cranberry products, methenamine hippurate for prevention of recurrence of rUTI. However, substantial heterogeneity in outcome reporting across randomised controlled trials (RCTs) evaluating both treatment and preventions for rUTI hampers the pooling and synthesis of study results, ultimately limiting evidence-based clinical decision-making and guideline development.
Previously, a core outcome set for uncomplicated UTI (COSUTI) was established, which provides a reference for outcome formulation in RCTs during acute treatment of single-episode uncomplicated UTIs in healthy adults. However, rUTI and uncomplicated UTI are different disease entities. rUTI is is driven by unique pathophysiological mechanisms, including urothelial barrier dysfunction, intracellular bacterial persistence, genitourinary microbiome dysbiosis, and impaired local mucosal immunity.Thus, rUTI is recognised as a separate, independent chapter in major international guidelines. Additionally, the management of rUTI involves both treatment of acute episodes and prevention of recurrence. COSUTI was designed exclusively for the short-term treatment of acute episodes and did not cover the long-term outcome of prevention for recurrences. Thus, COSUTI cannot be directly applied to rUTI trials.
The aim of this study is to develop core outcome set for recurrent urinary tract infection (COSrUTI) through a rigorous, multi-stakeholder consensus process. The COSrUTI will specify the minimum outcomes that should be measured and reported in all future clinical trials evaluating both treatment and preventive interventions for in adults with rUTI. Standardisation through COSrUTI will increase homogeneity across studies, reduce outcome reporting bias, facilitate evidence synthesis, and ultimately inform clinical guideline development and improve patient care.
Guobin Su: The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Nuffield Department of Population Health, University of Oxford, Oxford, UK
Xindong Qin: The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Zehuai Wen The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Lihong Yang The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
David W Johnson: Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.
Suzanne E Geerlings:Amsterdam UMC, University of Amsterdam, Infectious Diseases, Amsterdam, The Netherlands
Zhiyao Li: The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Tingxian Zhao: The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Yibo Wang: The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Xiji Lin: The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Xinxin Chen:The second clinical college of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese medicine, Guangzhou, China
Disease Category: Urology
Disease Name: Urinary Tract Infection, Recurrent urinary tract infection
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
(1) We will systematically search for RCTs evaluating both treatment and preventive interventions for rUTI in adults and extract all reported outcome measures. Outcomes will be tabulated by intervention type for stratified analysis, and grouped into domains to form the candidate outcome list.
(2) A multi-stakeholder panel including healthcare professionals, researchers, policy makers and patients with rUTI experience will participate in several rounds Delphi survey. Participants will score each outcome on a 9-point Likert scale. Predefined consensus criteria will be applied to identify outcomes for retention.
(3) A consensus workshop will be convened with representatives from each stakeholder group to discuss outcomes that did not reach consensus in the Delphi survey, resolve inter-group disagreements, and confirm the final composition of COSrUTI through a structured voting process. Final voting will be conducted to determine the core outcome set.