Current status and progression of lower urinary tract symptoms in Chinese male patients: the protocol and rationale for a nationwide, hospital-based, prospective, multicentre study

INTRODUCTION: It has become increasingly evident that the male lower urinary tract symptoms (LUTS) may not only be caused by abnormalities in one or more components of the lower urinary tract, but also be secondary to a range of systemic disorders. The primary aim of this study is to evaluate the features of urological and systemic disorders among middle-aged and elderly male LUTS patients in China. The second aim is to investigate the changes of both conditions after interventions through a 2-year prospective follow-up. METHODS AND ANALYSIS: This nationwide, hospital-based, multicentre cohort study was designed and initiated by the Prostatic Obstruction Investigation Team which is an international multidisciplinary academic group focusing on the management of male LUTS. An expectation of 11 500 eligible subjects from 23 authorised urological centres across the mainland of China will be recruited with a baseline assessment and data collection. Subsequently, subjects will undergo a follow-up for 24 months having been prescribed with oral medications or after being selected for prostate surgery based on the standard practice of each institution as well as the clinician’s own experience. All statistical analysis will be performed using SAS V.9.4 and R package. ETHICS AND DISSEMINATION: This study has received ethical approval from the Ethics Committee Boards of Shanghai Changhai Hospital (CHEC2017-244). The results will be reported at scientific conferences and be published on peer-reviewed journals. TRIAL REGISTRATION: NCT03394651.