Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia using Patient-Reported Outcomes: Protocol for a Prospective Observational Study

Author:

Glaser Alexander P.1,Smith Abigail R.2,Maglaque Dacey1,Helfand Brian T.1,Mohamed Rowida3,An Hosanna3,Marquez Melissa3,Talaty Pooja1,Carolan Padraig2,Geller Aaron M.2,Farina Francesca R.3,Jensen Sally E.2,Griffith James W.3

Affiliation:

1. NorthShore University HealthSystem

2. Northwestern University

3. University of Chicago

Abstract

Abstract

Background 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.Methods 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.Discussion 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.Trial registration: This study is registered in ClinicalTrials.gov (NCT05898932).

Publisher

Research Square Platform LLC

Reference38 articles.

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2. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023;Sandhu JS;J Urol,2024

3. Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms;Gravas S;Eur Urol,2023

4. The rising worldwide impact of benign prostatic hyperplasia;Launer BM;BJU Int,2021

5. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association;Barry MJ;J Urol,1992

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