Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes

NCT ID: NCT05898932

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-08-31

Brief Summary

The goal of this project is to use newly developed patient-reported outcomes to improve the clinical care of patients with benign prostatic hyperplasia. The use of new patient-centered tools will improve evaluation and clinical decision-making by including symptoms not commonly measured in men, such as urinary incontinence, and allow for more frequent assessment of lower urinary tract symptoms through remote surveillance. Through the use of care-coordination checklists, clinicians can be more responsive to post-treatment symptom changes, resulting in reduced bother from lower urinary tract symptoms and higher quality of life in patients with benign prostatic hyperplasia.

Detailed Description

The American Urological Association Symptom Index (AUA-SI) has been the primary patient-reported outcome (PRO) used in men with benign prostatic hyperplasia (BPH) for decades. New symptom indices - the LURN SI-10 and LURN SI-29 - have been developed by the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) to provide a general-use multidimensional symptom assessment in the urology clinic. These tools are relatively new and have yet to be validated in specific disease populations. The overarching goal of this project is to use these new questionnaires to enhance clinical decision-making in men with BPH. This will be achieved by (1) integration of PRO assessments into the evaluation and management of patients with BPH; (2) determination of clinical meaningful differences in LURN symptom indices in men with BPH receiving known effective treatment; and (3) creation of data visualization tools and care-coordination recommendations to facilitate the matching of evidence-based treatments to patients with persistent symptoms using PROs. PROs provide a cost-effective remote management strategy that, combined with advances in electronic medical health record technology, can improve patient care by allowing for more real-time surveillance and intervention, and the monitoring of common comorbid symptoms such as sleep disturbance and depression, in addition to core urologic symptoms of BPH.

In Aim 1, the investigators will use sophisticated statistical methods to predict changes in urological symptoms and assess associations between lower urinary tract symptoms and measures of sleep, depression, and pain, among others. In Aim 2, the investigators will assess test-retest reliability and other psychometric properties of the LURN symptom indices, using a triangulation of methods to determine minimally important differences. Finally in Aim 3, the investigators will engage stakeholders, including patients and clinicians, and use qualitative methods to create visualization tools and care coordination checklists to improve counseling and follow up for patients undergoing treatment. Aim 3 will also enhance the recovery and routine monitoring of men with BPH after surgery, who can experience distressing side effects and complications such as urinary leakage and pain.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Medical Management

Participants will be managing condition with medication

Medical Management

Intervention Type: OTHER

Participants will be managing condition with medication

Surgical Management

Participants will be managing condition with a surgery

Surgical Management

Intervention Type: OTHER

Participants will be managing condition with a surgery

Interventions

Medical Management

Participants will be managing condition with medication

Intervention Type: OTHER

Surgical Management

Participants will be managing condition with a surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male sex

2. Age 50 years or older

3. Diagnosed by physician with BPH

4. Able and willing to complete questionnaires

5. Able and willing to provide informed consent

6. Ability to read, write, and speak in English

7. No plans to move from study area in next 6 months

Exclusion Criteria

1. Female sex or intersex

2. Younger than 50 years of age

3. Being a prisoner or detainee

4. Gross hematuria

5. Interstitial cystitis

6. Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)

7. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy

8. Ongoing symptomatic urethral stricture

9. Current chemotherapy or other cancer therapy

10. History of lower urinary tract or pelvic malignancy

11. Severe neurological of psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)

12. Current moderate or severe substance use disorder

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

James W Griffith

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James W. Griffith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Alexander P. Glaser, MD

Role: PRINCIPAL_INVESTIGATOR

NorthShore University HealthSystem, Department of Surgery, Division of Urology

Abigail R. Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

NorthShore University HealthSystem Research Institute

Glenview, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dacey Maglaque

Role: CONTACT

dmaglaque2@northshore.org

847-503-4278

Pooja Talaty

Role: CONTACT

PTalaty@northshore.org

847-503-4280

Facility Contacts

Dacey Maglaque

Role: primary

dmaglaque2@northshore.org

847-503-4278

Pooja Talaty

Role: backup

PTalaty@northshore.org

847-503-4280

References

Glaser AP, Smith AR, Maglaque D, Helfand BT, Mohamed R, An H, Marquez M, Talaty P, Carolan P, Geller AM, Farina FR, Jensen SE, Griffith JW. Enhanced clinical decisions for management of benign prostatic hyperplasia using patient-reported outcomes: protocol for a prospective observational study. BMC Urol. 2024 May 21;24(1):110. doi: 10.1186/s12894-024-01500-0.

Reference Type: BACKGROUND

PMID: 38773430 (View on PubMed)

Glaser AP, Smith AR, Maglaque D, Helfand BT, Mohamed R, An H, Marquez M, Talaty P, Carolan P, Geller AM, Farina FR, Jensen SE, Griffith JW. Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia using Patient-Reported Outcomes: Protocol for a Prospective Observational Study. Res Sq [Preprint]. 2024 May 6:rs.3.rs-4308293. doi: 10.21203/rs.3.rs-4308293/v1.

Reference Type: DERIVED

PMID: 38766034 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://bmcurol.biomedcentral.com/articles/10.1186/s12894-024-01500-0

This protocol outlines the rationale and methods to: (1) integrate PROs for better BPH care; (2) assess psychometric properties of the LURN SIs; and (3) develop care-coordination recomm

Other Identifiers

STU00217126

Identifier Type: -

Identifier Source: org_study_id