This trial aims to assess the safety and effectiveness of prostate artery embolization (PAE – blocking off part of the blood supply to the prostate) to treat urinary symptoms of an enlarged prostate. The main outcome to be measured is side effects from this treatment over 12 months. This trial is being conducted in Chicago, Illinois.
The details
Benign prostatic hyperplasia (BPH – an enlarged prostate) can cause problems with bladder function. Treatment includes medication, however, this may not be effective in all men. PAE involves using a bead particle to block off some of the blood supply to an enlarged prostate. This may help to shrink the enlarged tissue. It is necessary to assess the safety and effectiveness of PAE treatment.
The main outcome of this trial is to measure the side effects of PAE. It will also measure change in prostate size and bladder function.
Who are they looking for?
This study will recruit 30 participants. Participants should have urinary symptoms due to BPH, and a high PSA (prostate specific antigen).
Participants should not have a history of prostate or bladder cancer, bladder stones, kidney failure, or be on medication to treat the prostate. Participants should not have uncontrolled diabetes, overactive bladder, prior treatment for incontinence, or history of rectal cancer. Men who wish to remain fertile will be excluded.
How will it work
All patients will undergo PAE as part of this study. Participants will use a pad daily to measure urine and bladder function. After PAE, participants will be followed up at 4 weeks, 12 weeks, 6 months, and 12 months.
