Improving care for men with benign prostatic hyperplasia using patient feedback
Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
This study is testing if using feedback from men with benign prostatic hyperplasia can help doctors provide better care and improve their quality of life by focusing on a wider range of symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, Cytoxan |
| Locations | 1 site (Glenview, Illinois) |
| Trial ID | NCT05898932 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the clinical management of benign prostatic hyperplasia (BPH) by utilizing newly developed patient-reported outcomes (PROs) that capture a broader range of symptoms, including urinary incontinence. The study will integrate these PRO assessments into patient evaluations and treatment decisions, allowing for more responsive care through remote monitoring and care-coordination checklists. By employing advanced statistical methods, the research will identify clinically meaningful differences in symptom indices among men receiving effective treatments for BPH. The ultimate goal is to improve patient quality of life by addressing persistent symptoms more effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 50 years or older who have been diagnosed with benign prostatic hyperplasia and are willing to complete questionnaires.
Not a fit: Patients who are female, younger than 50, or have certain medical conditions such as severe neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved symptom management and quality of life for patients with benign prostatic hyperplasia.
How similar studies have performed: Other studies have shown promise in using patient-reported outcomes to enhance clinical decision-making, but the specific application of the new LURN symptom indices in BPH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glenview, Illinois
- NorthShore University HealthSystem Research Institute — Glenview, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: James W. Griffith, PhD — University of Chicago
- Study coordinator: Dacey Maglaque
- Email: dmaglaque2@northshore.org
- Phone: 847-503-4278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.