Actively Recruiting
Comparing Prostate Artery Embolization to Surgery for Treating Enlarged Prostate Symptoms Randomized Study on Treatment Safety, Recovery, and Quality of Life
Led by Oslo University Hospital · Updated on 2023-12-27
140
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating prostate artery embolization PAE compared to the established surgical treatment for men with lower urinary tract symptoms LUTS caused by an enlarged benign prostate. The study aims to assess patient acceptance, morbidity, complications, and functional outcomes, as well as length of hospital stay, costs, and recovery time. Both treatments are being studied to help select the best option for patients. A total of 140 men will be randomly assigned to one of the two treatments. Before treatment, patients undergo computed tomography angiography to determine eligibility based on their pelvic arteries, and magnetic resonance imaging to rule out prostate cancer. PAE involves placing a catheter in an artery in the groin under local anesthesia to inject small particles into the prostate arteries. Surgery is performed under general anesthesia either through the penis catheter for small prostates or through a lower abdomen incision for larger prostates. All patients stay in the urology unit after treatment. Follow-up visits occur at 3 months, 1 year, and 5 years to record acute and long-term complications. Participants will have clinical visits to assess urinary symptoms and quality of life using questionnaires, and urodynamic examinations measure functional outcomes. Researchers will also track hospital stay length, costs, and recovery time. The main outcomes include quality of life related to urinary symptoms at 3 months and the number of patients who avoid surgery after PAE at 12 months. This study helps provide important information for international guidelines and treatment decisions for benign prostatic hyperplasia.
CONDITIONS
Brief Title
Artery Embolization vs Operation of Benign Prostate Hyperplasia
Research Team
T
Thijs Hagen, MD
E
Eduard Baco, MD, PHD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here