Disease Progression and Outcomes in Chinese Patients with Benign Prostatic Hyperplasia: A Multicenter Retrospective Cohort Study Protocol (Preprint)

BACKGROUND Benign prostatic hyperplasia (BPH) is highly prevalent among aging men and may lead to progressive lower urinary tract symptoms, surgical intervention, or severe outcomes such as acute urinary retention, bladder stones, and renal impairment. Comprehensive long-term studies on BPH progression and outcomes in Chinese populations are limited. OBJECTIVE This study aims to analyze disease trajectories, risk factors, and key outcomes of BPH, and to develop predictive models using multicenter retrospective data from the PLA General Hospital network. METHODS We will establish a retrospective cohort of BPH patients with multiple visits across PLA General Hospital centers. The index date is defined as the first hospital visit for BPH. Patients will be followed via outpatient, inpatient, and health examination data until BPH-related endpoints, loss to follow-up, or death. Exclusions include follow-up <180 days, prostate cancer, neurogenic bladder, urethral stricture, pelvic radiotherapy, or incomplete records. Data will include baseline characteristics, comorbidities, treatments, and outcomes. Cox regression will be used to assess risk factors, and Kaplan–Meier methods to estimate cumulative incidence. RESULTS The study protocol has been approved by the Ethics Committee of the PLA General Hospital (Approval Number: S2022-700-01). The study will be conducted in strict accordance with the Declaration of Helsinki. Data will be de-identified and restricted to the research team. Findings will be published in peer-reviewed journals, and de-identified data may be shared with qualified investigators upon request. CONCLUSIONS Despite the limitations inherent to retrospective studies, the strengths of this multicenter, long-term design and rigorous methodology position this study to make significant contributions to the understanding of BPH natural history. Its findings are expected to provide high-quality evidence for clinical management, risk stratification, and precision intervention, ultimately improving patient outcomes and informing healthcare policy. CLINICALTRIAL