Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Management, Surgical Management.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Medical Management
Participants will be managing condition with medication - Other Surgical Management
Participants will be managing condition with a surgery
Primary outcome measures
- Patient rating of global change [Time frame: Through study completion, from week 4 to week 24]
- LURN SYMPTOM INDEX-29 (LURN SI-29) [Time frame: The past 7 days]
- The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1 [Time frame: The past 7 days]
- AMERICAN UROLOGICAL ASSOCIATION (AUS) SYMPTOM SCORE [Time frame: The past 30 days]
Secondary outcome measures (9)
- Sexual Health Inventory for Men (SHIM) Questionnaire [Time frame: The past 6 months]
- The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a [Time frame: In the past 7 days]
- The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a [Time frame: In the past 7 days]
- Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) [Time frame: In the past month.]
- The snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire [Time frame: Not Applicable (NA)]
- 3-Day Voiding Diary [Time frame: Recorded on three separate days]
- The National Cancer Institute (NCI) Quick Food Scan [Time frame: in the past 12 months]
- The Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function- Short Form 4a [Time frame: In the past 7 days]
- The Patient Feedback Survey [Time frame: Immediate - This questionnaire is about survey burden in regard to the study]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NorthShore University HealthSystem Research Institute — Glenview
Publications
- 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
- 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
Identifiers
NCT: NCT05898932 · STU00217126