Clinical trial NCT05898932: Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
Official title: Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Prostatic Hyperplasia
Keywords: PROs
Questionnaires
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
BPH
LUTS
Patient reported outcome measures
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Endeavor Health
name: University of Chicago
First posted: 2023-06-12
Enrollment: 300
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with benign prostatic hyperplasia

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.

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

Primary outcomes:
measure: Patient rating of global change
timeFrame: Through study completion, from week 4 to week 24
measure: LURN SYMPTOM INDEX-29 (LURN SI-29)
timeFrame: The past 7 days
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1
timeFrame: The past 7 days
measure: AMERICAN UROLOGICAL ASSOCIATION (AUS) SYMPTOM SCORE
timeFrame: The past 30 days
Secondary outcomes:
measure: Sexual Health Inventory for Men (SHIM) Questionnaire
timeFrame: The past 6 months
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a
timeFrame: In the past 7 days
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a
timeFrame: In the past 7 days
measure: Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
timeFrame: In the past month.
measure: The snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire
timeFrame: Not Applicable (NA)
measure: 3-Day Voiding Diary
timeFrame: Recorded on three separate days
measure: The National Cancer Institute (NCI) Quick Food Scan
timeFrame: in the past 12 months
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function- Short Form 4a
timeFrame: In the past 7 days
measure: The Patient Feedback Survey
timeFrame: Immediate - This questionnaire is about survey burden in regard to the study
Other outcomes:
Locations:
city: Glenview
country: United States
facility: NorthShore University HealthSystem Research Institute
state: Illinois
Study officials:
affiliation: University of Chicago
name: James W. Griffith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NorthShore University HealthSystem, Department of Surgery, Division of Urology
name: Alexander P. Glaser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Abigail R. Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.