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

NCT05898932 | Recruiting DMC

• 1 other identifier: STU00217126
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

PROs; Questionnaires; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; BPH; LUTS; Patient reported outcome measures

Outcome Measures

Primary Outcomes (4)

• Patient rating of global change

  This is a single item that captures how much better or worse the person's bladder condition is relative to when they began treatment for BPH. The Patient Global Rating of Change (PGRC) scale ranges from "Very much worse" (1) to "Very much improved" (7), with higher scores indicating a better outcome.

  Through study completion, from week 4 to week 24

• LURN SYMPTOM INDEX-29 (LURN SI-29)

  This is a multidimensional questionnaire that assesses different lower urinary tract symptoms as well as single item about global bother.

  The past 7 days

• The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1

  The PROMIS-29 Profile-a 29-item instrument-combines short assessments of eight core constructs of health-related quality of life (HRQoL): physical function (PF), sleep disturbance (SD), pain interference (PI) and pain intensity (PIN), fatigue (FA), anxiety (AN), depression (DE) and ability to participate in social roles and activities (SRAA). PROMIS employs a T-score, which is constructed such that 50 is the mean of the general population, and the standard deviation is 10 by definition. Most scores falling between 20 and 80, which is +/- 3 SDs around the mean. Higher scores represent more of a domain. Therefore, for physical function, higher scores represent better health whereas for anxiety, higher scores represent poorer health.

  The past 7 days

• AMERICAN UROLOGICAL ASSOCIATION (AUS) SYMPTOM SCORE

  This is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms. ranges from 0 to 35, with higher scores indicating more severe urinary symptoms.

  The past 30 days

Secondary Outcomes (9)

• Sexual Health Inventory for Men (SHIM) Questionnaire

  The past 6 months

• The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a

  In the past 7 days

• The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a

  In the past 7 days

• Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)

  In the past month.

• The snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire

  Not Applicable (NA)

Study Arms (2)

Medical Management

Participants will be managing condition with medication

Other: Medical Management

Surgical Management

Participants will be managing condition with a surgery

Other: Surgical Management

Interventions

Medical Management OTHER

Participants will be managing condition with medication

Medical Management

Surgical Management OTHER

Participants will be managing condition with a surgery

Surgical Management

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with benign prostatic hyperplasia

You may qualify if:

• Male sex
• Age 50 years or older
• Diagnosed by physician with BPH
• Able and willing to complete questionnaires
• Able and willing to provide informed consent
• Ability to read, write, and speak in English
• No plans to move from study area in next 6 months

You may not qualify if:

• Female sex or intersex
• Younger than 50 years of age
• Being a prisoner or detainee
• Gross hematuria
• Interstitial cystitis
• Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)
• History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy
• Ongoing symptomatic urethral stricture
• Current chemotherapy or other cancer therapy
• History of lower urinary tract or pelvic malignancy
• Severe neurological of psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)
• Current moderate or severe substance use disorder

Sponsors & Collaborators

• Northwestern University: lead
• Endeavor Health: collaborator
• University of Chicago: collaborator

Study Sites (1)

NorthShore University HealthSystem Research Institute

Glenview, Illinois, 60026, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 38773430 BACKGROUND

• 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.

  PMID: 38766034 DERIVED

Related Links

• 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

Biospecimen

Retention: SAMPLES WITH DNA

Participants will have the option to consent to contributing to a biobank, which would contain DNA and other specimens.

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• James W. Griffith, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Alexander P. Glaser, MD

  NorthShore University HealthSystem, Department of Surgery, Division of Urology

  PRINCIPAL INVESTIGATOR

• Abigail R. Smith, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dacey Maglaque

CONTACT

847-503-4278; dmaglaque2@northshore.org

Pooja Talaty

CONTACT

847-503-4280; PTalaty@northshore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)