Enhanced clinical decisions for management of benign prostatic hyperplasia using patient-reported outcomes: protocol for a prospective observational study.

Lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) significantly impact quality of life among older men. Despite the prevalent use of the American Urological Association Symptom Index (AUA-SI) for BPH, this measure overlooks key symptoms such as pain and incontinence, underscoring the need for more comprehensive patient-reported outcome (PRO) tools. This study aims to integrate enhanced PROs into routine clinical practice to better capture the spectrum of LUTS, thereby improving clinical outcomes and patient care.

This prospective observational study will recruit men with LUTS secondary to BPH aged ≥ 50 years from urology clinics. Participants will be stratified into medical and surgical management groups, with PRO assessments scheduled at regular intervals to monitor LUTS and other health outcomes. The study will employ the LURN Symptom Index (SI)-29 alongside the traditional AUA-SI and other non-urologic PROs to evaluate a broad range of symptoms. Data on comorbidities, symptom severity, and treatment efficacy will be collected through a combination of electronic health records and PROs. Analyses will focus on the predictive power of these tools in relation to symptom trajectories and treatment responses. Aims are to: (1) integrate routine clinical tests with PRO assessment to enhance screening, diagnosis, and management of patients with BPH; (2) examine psychometric properties of the LURN SIs, including test-retest reliability and establishment of clinically meaningful differences; and (3) create care-coordination recommendations to facilitate management of persistent symptoms and common comorbidities measured by PROs.

By employing comprehensive PRO measures, this study expects to refine symptom assessment and enhance treatment monitoring, potentially leading to improved personalized care strategies. The integration of these tools into clinical settings could revolutionize the management of LUTS/BPH by providing more nuanced insights into patient experiences and outcomes. The findings could have significant implications for clinical practices, potentially leading to updates in clinical guidelines and better health management strategies for men with LUTS/BPH.

This study is registered in ClinicalTrials.gov (NCT05898932).

BMC urology. 2024 May 21*** epublish ***

Alexander P Glaser, Abigail R Smith, Dacey Maglaque, Brian T Helfand, Rowida Mohamed, Hosanna An, Melissa Marquez, Pooja Talaty, Padraig Carolan, Aaron M Geller, Francesca R Farina, Sally E Jensen, James W Griffith

Department of Surgery, Division of Urology, Endeavor Health (Formerly NorthShore University HealthSystem), Evanston, IL, USA., Feinberg School of Medicine, Department of Preventive Medicine, Division of Biostatistics, Northwestern University, Chicago, IL, USA., Pritzker School of Medicine, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA., Center for Interdisciplinary Exploration and Research in Astrophysics (CIERA), Department of Physics & Astronomy, Northwestern University, Chicago, IL, USA., Feinberg School of Medicine, Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA., Pritzker School of Medicine, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA. .