OBJECTIVES: The objectives of PURE are to understand the direct cost of urinary incontinence (UI); describe the impact of UI on health-related quality of life (HRQOL); and describe the treatment patterns for women with UI in Europe in an outpatient setting. METHODS: PURE is an ongoing, prospective, observational study. More than 9000 patients will be recruited in 13 European countries. The participating investigators are primary care physicians and specialists (urologists, gynaecologists, geriatricians). The data will be prospectively collected at baseline and at 2 points over a 6-month period. Assessments include health care resource utilisation and treatments to derive direct medical costs of UI care and describe the treatment patterns, as well as symptoms and severity of UI and impact of UI on patients' lives. Baseline evaluation will additionally include demographics, medical history, the assessment of HRQOL and a retrospective data collection on health care resource utilisation in the previous 12 months. RESULTS: By considering all the 10 priority research areas on the economics of UI identified by the 2nd international consultation on incontinence, PURE provides a unique opportunity to assess the direct medical costs for UI care in women across Europe. This will give insights to the economic burden from the perspective of the national health care systems, as well as from the patient, and will allow comparisons of treatment patterns between countries in the light of different health care systems and access to care. To our knowledge this is the first study undertaken in an outpatient setting to investigate the economic and human impact of UI in Europe. CONCLUSIONS: PURE will address relevant clinical, economic and policy research questions and will provide large-scale, comparative, real-world information on the treatment and burden of UI across Europe; data currently missing from the European literature but needed to guide effective health policy.