Benign Prostatic HyperplasiaNCT05898932
Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
An observational study of Benign Prostatic Hyperplasia, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Medical Management and Surgical Management
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with benign prostatic hyperplasia
Who may be able to join
- Male sex
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Glenview, Illinois, 60026
Dacey Maglaque, 847-503-4278, dacey.maglaque@endeavorhealth.org
Pooja Talaty, 847-503-4280, pooja.talaty@endeavorhealth.org
About this study
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Medical Management, Surgical Management
- Keywords
- PROs, Questionnaires, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, BPH, LUTS, Patient reported outcome measures
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ManagementOther
Participants will be managing condition with medication
Surgical ManagementOther
Participants will be managing condition with a surgery
| Study group | Role | What they receive |
|---|---|---|
| Medical Management | Participants will be managing condition with medication Receives: Other: Medical Management | |
| Surgical Management | Participants will be managing condition with a surgery Receives: Other: Surgical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The past 30 days
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediate - This questionnaire is about survey burden in regard to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Endeavor Health, University of Chicago
- Responsible party
- Principal investigator, Abigail Smith, University of Chicago
- Investigators
- James W. Griffith, PhD, Principal investigator, University of ChicagoAlexander P. Glaser, MD, Principal investigator, Endeavor Health, Department of Surgery, Division of UrologyAbigail R. Smith, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898932
- Sponsor's protocol ID
- STU00217126
- Status last verified
- Aug 2026
- First submitted
- 16 May 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be shared with other researchers.
Publications
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.
PubMed 38773430Glaser 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. Res Sq [Preprint]. 2024 May 6:rs.3.rs-4308293. doi: 10.21203/rs.3.rs-4308293/v1.
PubMed 38766034
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT05898932
- Acronym / sponsor ID
- STU00217126
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- PROs, Questionnaires, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, BPH, LUTS, Patient reported outcome measures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Endeavor Health, University of Chicago
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Management | – | Other: Medical ManagementParticipants will be managing condition with medication |
| Surgical Management | – | Other: Surgical ManagementParticipants will be managing condition with a surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with benign prostatic hyperplasia
Key inclusion criteria (7 listed)
- Male sex
- Age 50 years or older
- Diagnosed by physician with BPH
- Able and willing to complete questionnaires
- Able and willing to provide informed consent
Key exclusion criteria (12 listed)
- Female sex or intersex
- Younger than 50 years of age
- Being a prisoner or detainee
- Gross hematuria
- Interstitial cystitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical ManagementParticipants will be managing condition with medication | Other | Medical Management |
| Surgical ManagementParticipants will be managing condition with a surgery | Other | Surgical Management |
Primary outcome
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.
9 secondary outcomes
Sexual Health Inventory for Men (SHIM) Questionnaire
Time frame: The past 6 months
The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a
Time frame: In the past 7 days
The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a
Time frame: In the past 7 days
Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
Time frame: In the past month.
The snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire
Time frame: Not Applicable (NA)
3-Day Voiding Diary
Time frame: Recorded on three separate days
The National Cancer Institute (NCI) Quick Food Scan
Time frame: in the past 12 months
The Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function- Short Form 4a
Time frame: In the past 7 days
The Patient Feedback Survey
Time frame: Immediate - This questionnaire is about survey burden in regard to the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 38773430Glaser 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.
- Derived from this study: PubMed 38766034Glaser 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. Res Sq [Preprint]. 2024 May 6:rs.3.rs-4308293. doi: 10.21203/rs.3.rs-4308293/v1.
- This protocol outlines the rationale and methods to: (1) integrate PROs for better BPH care; (2) assess psychometric properties of the LURN SIs; and (3) develop care-coordination recommLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified data may be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James W. Griffith, PhD principal investigator
University of Chicago
Alexander P. Glaser, MD principal investigator
Endeavor Health, Department of Surgery, Division of Urology
Abigail R. Smith, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dacey Maglaque (847-503-4278, dacey.maglaque@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rating of global change (time frame: Through study completion, from week 4 to week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05898932, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.