This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.
International Prostate Symptom Score
A survey accessing patient symptomology from BPH induced LUTS
Time frame: 6 months
International Prostate Symptom Score
A survey accessing patient symptomology from BPH induced LUTS
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Quality of Life
A survey accessing quality of life impact on patients from BPH induced LUTS.
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Maximal urinary flow rate change from baseline
Maximal flow rate of urine stream
Time frame: 6, 12, 24, and 36 months
Post void residual change from baseline
Post void residual measures the volume of urine remaining in the bladder after complete emptying.
Time frame: 6, 12, 24, and 36 months
International Index of Erectile Function questionnaire (IIEF)
A questionnaire designed to asses erectile function
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Freedom from secondary intervention to treat BPH
Recording of other surgical/procedural treatments with each procedure being recorded as an event.
Time frame: 1, 3, 6, 9, 12, 24, 36 months
Ejaculatory function
Ejaculatory function will be assessed utilizing a four item questionnaire.
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Time frame: 3, 6, 9, 12, 24, 36 months
Urinary Continence
Urinary Continence will be assessed using a 2 item questionnaire
Time frame: 1, 6, and 12 months
Number of hospital days
Number of hospital days following the procedure will be recorded
Time frame: 1 month
Recover experience
Recover experience will be assessed using a quality of recovery visual analog scale
Time frame: 1 month
Adverse events
All procedure related adverse events will be recoreded
Time frame: 7 days and 1, 3, 6, 9, 12, 24, 36 months