NCT05898932 · Northwestern University
Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
What this study is about
The goal of this project is to use newly developed patient-reported outcomes to improve the clinical care of patients with benign prostatic hyperplasia.
View original scientific description
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.
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
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)
Time frame: The past 7 days
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
Time frame: The past 7 days
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
Time frame: The past 30 days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Glenview, Illinois
Collaborators
Endeavor Health, University of Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations