NCT05898932 Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
| NCT ID | NCT05898932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-06-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
James W. Griffith, PhD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT05898932 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05898932 currently recruiting?
Yes, NCT05898932 is actively recruiting participants. Contact the research team at dmaglaque2@northshore.org for enrollment information.
Where is the NCT05898932 trial being conducted?
This trial is being conducted at Glenview, United States.
Who is sponsoring the NCT05898932 clinical trial?
NCT05898932 is sponsored by Northwestern University. The principal investigator is James W. Griffith, PhD at University of Chicago. The trial plans to enroll 300 participants.