An observational study in Benign Prostatic Hyperplasia, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Northwestern University · Observational
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.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 300 is above the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men with benign prostatic hyperplasia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be managing condition with medication
Other: Medical Management
Participants will be managing condition with a surgery
Other: Surgical Management
Participants will be managing condition with medication
Participants will be managing condition with a surgery
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
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
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
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
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
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
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
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.
The snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire
The STOP-Bang questionnaire is a scoring model consisting of eight easily administered questions starting with the acronym STOP-Bang (Appendix) and is scored based on Yes/No answers (score: 1/0). Thus, the scores range from a value of 0 to 8. Higher score indicating worse outcome.
Time frame: Not Applicable (NA)
3-Day Voiding Diary
The diary records the patient's daily fluid intake, frequency of urination throughout the day and night, instances of leakage, and the quantity of lost urine. Analyzing these findings against the standard criteria for regular bladder function could reveal potential issues and help confirm a diagnosis. The definition of normal benchmarks takes into account factors like age, gender, as well as various internal and external variables including fluid consumption and its nature.
Time frame: Recorded on three separate days
The National Cancer Institute (NCI) Quick Food Scan
National Cancer Institute Quick Food Scan estimates fat intake as a percentage of total energy. Participants rate their frequency of consuming 15 food groups and reduced-fat butter or margarine over the last 12 months ranging 1 = never to 8 = more than once per day. Reduced-fat margarine usage as a replacement for butter is rated separately. Scoring is based on weighted least-squares estimates of regression coefficients for data from the U.S. Department of Agriculture's 1994-1996 Continuing Survey of Food Intakes by Individuals. The algorithm accounts for food frequency with age- and sex-specific portion sizes. The final score is expressed as total estimated percentage of dietary energy from fat.
Time frame: in the past 12 months
The Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function- Short Form 4a
The PROMIS® v2.0 Cognitive Function short forms measure participants' subjectively experienced cognitive functioning. Individuals may select one of five options in response: "5-never," "4-rarely (once)," "3-sometimes (2-3 times)," "2-often (about once a day)," and "1-very often (several times a day)." PROMIS scales are expressed on a T score, where 50 is the mean of the general population, with a standard deviation of 10 by definition. Most scores fall between 20 and 80, +/- 3 SDs around the mean. Higher scores represent more of a domain. Lower raw scores and lower T scores on this measure indicate greater subjective cognitive difficulty.
Time frame: In the past 7 days
The Patient Feedback Survey
The Patient Feedback Survey is a brief six-item PRO measure that captures how the patient perceives PROMs administered in terms of burdensomeness. A composite score is calculated to create a weighted representative index of concern, comfort, and well-being relative to time to completion for a range of 0 to 72, with higher scores indicative of elevated endorsed response burden.
Time frame: Immediate - This questionnaire is about survey burden in regard to the study
Plan to share: No — De-identified data may be shared with other researchers.
Started Jun 2023 (actual). Primary completion is estimated for Apr 2027, 46 months after the start.
Of 59 non-industry observational studies under Prostatic Hyperplasia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 46 months is above that.
Counting every sponsor, half of 74 studies reached it within 25 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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