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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50+
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Medical Management

    Other intervention

    Participants will be managing condition with medication

  • Surgical Management

    Other intervention

    Participants will be managing condition with a surgery

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Medical Management1 intervention
Group B: Surgical Management1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, from week 4 to week 24
2

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.

Time frame
The past 7 days
3

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.

Time frame
The past 7 days
4

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.

Time frame
The past 30 days

Secondary outcomes

1

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.

Time frame
The past 6 months
2

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

Time frame
In the past 7 days
3

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.

Time frame
In the past 7 days
4

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

Time frame
In the past month.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

University of Chicago

Sponsor institution

Endeavor Health

Collaborator

University of Chicago

Collaborator