Actively Recruiting
Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia
Led by Oslo University Hospital · Updated on 2023-12-27
140
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with moderate to severe lower urinary tract symptoms from benign prostate hyperplasia (IPSS score > 8) and quality of life score of 3 or higher
- Symptoms refractory to medical treatment for at least 6 months or patient unwilling to accept medical treatment
- Use of permanent or intermittent catheterization for BPH
- Prostate volume larger than 50 ml
- Signed informed consent
You will not qualify if you...
- Evidence of clinically significant prostate cancer on prostate biopsy
- Prostatitis or neurogenic bladder conditions such as detrusor-sphincter dyssynergia
- Urethral strictures, bladder neck contracture, bladder stones, or bladder cancer
- Renal insufficiency with Glomerular Filtration Rate less than 30 ml/min/1.73m2
- Known severe reactions to iodine-based or gadolinium-based contrast agents
- Previous prostate operation
- CT exam showing no access to the prostate arteries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for computed tomography angiography and magnetic resonance imaging
Duration - Hospital stay plus recovery time as determined by treating physicians
Participants undergo either prostate artery embolization or prostate surgery to treat lower urinary tract symptoms due to benign prostate hyperplasia.
1 procedure in radiology or operating room followed by hospital stay in the urology unit
Duration - Up to 5 years
Participants have clinical visits to assess quality of life, symptoms, and complications after treatment.
Clinical visits at 3 months, 1 year, and 5 years post-treatment
Trial Site Locations
Total: 1 location
1
Oslo University Hospital, Aker
Oslo, Norway
Actively Recruiting
Research Team
T
Thijs Hagen, MD
E
Eduard Baco, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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