Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia
Status unconfirmed · Not applicable
Conditions studied: Prostatic Hyperplasia, Benign Prostatic Hyperplasia (BPH), Prostatism, Lower Urinary Tract Symptoms (LUTS), Prostatic Hypertrophy, Hyperplasia, Male Urogenital Diseases, Genital Diseases, Male
In brief
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Key facts
- Study ID
- NCT02592473
- Run by
- University of Virginia
- People needed
- 50
- Starts
- 2015-11-01
- Expected to finish
- 2021-11-01
- Last updated by the study team
- 2019-04-17
Who can join
Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Patients between ages 45-80 years
- Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
- IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
- All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging
You may not qualify if…
- Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
- Cases of biopsy proven prostate cancer or urethral cancer.
- Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
- Patients who are classified as New York Heart Association Class III (Moderate), or higher.
- Patients with history of prior pelvic irradiation.
- Hypersensitivity reactions to contrast material not manageable with prophylaxis.
- Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.
Where it is running
- University of Virginia Health Systems — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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