Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT05898932

Conditions

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Medical Management

Surgical Management

Study Details

Brief 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 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.

Conditions

Benign Prostatic Hyperplasia

Study ID

NCT05898932

Start date

Jun 1, 2023

Status verified date

Aug, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male sex
2. Age 50 years or older
3. Diagnosed by physician with BPH
4. Able and willing to complete questionnaires
5. Able and willing to provide informed consent
6. Ability to read, write, and speak in English
7. No plans to move from study area in next 6 months

Exclusion Criteria:

1. Female sex or intersex
2. Younger than 50 years of age
3. Being a prisoner or detainee
4. Gross hematuria
5. Interstitial cystitis
6. Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)
7. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy
8. Ongoing symptomatic urethral stricture
9. Current chemotherapy or other cancer therapy
10. History of lower urinary tract or pelvic malignancy
11. Severe neurological of psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)
12. Current moderate or severe substance use disorder

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Medical Management

Participants will be managing condition with medication

Surgical Management

Participants will be managing condition with a surgery

Interventions

Medical Management

Participants will be managing condition with medication

Surgical Management

Participants will be managing condition with a surgery

Primary outcome measure

  • Patient rating of global change [ Time Frame: Through study completion, from week 4 to week 24 ]
  • LURN SYMPTOM INDEX-29 (LURN SI-29) [ Time Frame: The past 7 days ]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1 [ Time Frame: The past 7 days ]
  • AMERICAN UROLOGICAL ASSOCIATION (AUS) SYMPTOM SCORE [ Time Frame: The past 30 days ]

Central Contacts and Locations

Central contacts

Dacey Maglaque

847-503-4278dacey.maglaque@endeavorhealth.org

Pooja Talaty

847-503-4280pooja.talaty@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Dacey Maglaque

847-503-4278dacey.maglaque@endeavorhealth.org

Pooja Talaty

847-503-4280pooja.talaty@endeavorhealth.org

Principal Investigator:

Alexander P. Glaser, MD

More Information

Sponsor

Northwestern University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • PROs
  • Questionnaires
  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms
  • BPH
  • LUTS
  • Patient reported outcome measures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-24.