This phase 1/2 trial aims to the effectiveness of prostate artery embolization in treating very large prostate in patients with benign prostatic hyperplasia (BPH). The main outcome to be investigated is the change in urinary symptoms. The trial is recruiting in Rhode Island, USA.
The details
BPH can lead to bothersome urinary symptoms that often require surgery targeting the enlarged prostate tissue. Prostate artery embolization has been developed as a minimally invasive alternative to reduce prostate size without actually removing prostate tissue. During prostate artery embolization, a small catheter is placed in the groin. Particles are injected into the local arteries, which decreases blood supply to the prostate, and therefore reduces prostate size.
This study will examine the effectiveness of prostate artery embolization in patients with very large prostate glands (90 grams or more). Questionnaires, medical examinations, and imaging tests will measure improvements in urinary symptoms as well as any changes in prostate size and number of side effects. Information such as procedure time, length of hospital stay, and the use of medical materials used will also be recorded.
Who are they looking for?
This study will recruit about 50 men aged 50 years or more with moderate to severe urinary symptoms due to BPH. Participants should have a prostate size of 90 grams or more as confirmed by imaging tests. Urinary flow rate should be weak.
Patients cannot take part in the trial if they have a history of prostate or bladder cancer, pelvic radiation, prostate surgery, kidney/bladder stones, or bleeding disorder. Participants should not have severe incomplete bladder emptying. The current use of medication for urinary symptoms (including alpha-blockers, 5-alpha reductase inhibitors, anticholinergic medication, hormones, and steroids) will be assessed and may need to be stopped for at least 6 months before taking part. Urinary symptoms due to a neurological condition such as Parkinson’s disease will prevent patients from taking part. Participants should not have an immune disorder, poor kidney function, an active urinary tract infection, or any any significant or uncontrolled medical illnesses.
How will it work
All participants will undergo prostate artery embolization after an initial health screening. Questionnaires, medical examinations, and imaging tests will measure improvements in urinary symptoms as well as any changes in prostate size and number of side effects for up to 2 years. Information such as procedure time, length of hospital stay, and the use of medical materials used will be recorded on the day of the procedure.
