About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male sex
Age 50 years or older
Diagnosed by physician with BPH
Able and willing to complete questionnaires
Disqualifiers
Female sex or intersex
Younger than 50 years of age
Being a prisoner or detainee
Gross hematuria
Trial population
Men with benign prostatic hyperplasia
Trial design
Cohort
Prospective
Treatments tested in this trial
Medical Management
Other interventionParticipants will be managing condition with medication
Surgical Management
Other interventionParticipants will be managing condition with a surgery
Treatment groups
Trial outcomes
Primary outcomes
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.
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 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.
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.
Secondary outcomes
Sexual Health Inventory for Men (SHIM) Questionnaire
This is an instrument widely used measure of erectile function consisting of 5 questions. The severity of erectile dysfunction score is from 1 to 25, with 1 being the most severe and 25 being healthy.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a
This contains items focused on capturing the frequency, form, bothersomeness, impact, controllability, and predictability of bowel urgency during the past 7 days. PROMIS employs a T-score, which ranges from 0 to 100, with most scores falling between 20 and 80.Higher scores represent more of a domain
The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a
This assesses the frequency and intensity of incomplete evacuation, rectal pain, straining, and hard stools, as well as the need for manual extraction of stool. PROMIS employs a T-score, which ranges from 0 to 100, with most scores falling between 20 and 80. Higher scores represent more of a domain.
Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
A 4-item validated questionnaire used to assess ejaculatory dysfunction. Three questions relate to ejaculatory function items and 1 relates to ejaculation bother item. Ejaculatory function score is the sum of questions 1 to 3 and scores range from 1 to 15, with lower scores indicating more severe ejaculatory complaints. Bother score range from 0 to 5, with higher scores indicating greater bother
Sponsors and contacts
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Northwestern University
Lead sponsor
University of Chicago
Sponsor institution
Endeavor Health
Collaborator
University of Chicago
Collaborator