Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients
Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients
The primary objective is to assess whether prostatic artery embolization has a similar
 efficacy and safety profile as GreenLight PVP in treating patients with urinary retention
 secondary to benign prostate hyperplasia (BPH). Subjects who consent will be randomized to
 either the Prostate embolization (PAE) arm or to the GreenLight PVP arm.

 The primary endpoint of efficacy of the procedure is measured by the ability of the patient
 to void. The secondary endpoints recorded will include patients' satisfaction measured by
 International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and post-void residual
 urine volume (PVR) and prostate specific antigen (PSA) will be measured at 3, 6, and 12
 months post treatment. Also, reduction in prostate volume is considered by MRI
 preoperatively, 3 months and 12 months.
The primary objective is to assess whether prostatic artery embolization has a similar
 efficacy and safety profile compared to GreenLight PVP in treating patients with urinary
 retention secondary to benign prostate hyperplasia (BPH) that have failed medical management.

 The target population is composed of subjects referred to the urology department for
 treatment of BPH who have failed medical treatment, who present with permanent bladder
 catheterization and who meet the eligibility criteria.

 Subjects who consent will be randomized to either the Prostate embolization (PAE) arm or to
 the GreenLight PVP arm.

 The primary endpoint of efficacy of the procedure is measured by the successful removal of
 bladder catheter and ability of the patient to void. As well, the secondary endpoints
 recorded will be: International Prostate Symptom Score (IPSS), peak flow rate (Qmax) and
 post-void residual urine volume (PVP) and prostate specific antigen (PSA) will be measured at
 3, 6, and 12 months post treatment. Trans-rectal ultrasound (TRUS) will be performed for
 measurement of prostate volume for the stratified randomization process. All adverse events
 will be captured and analyzed. MRI will be performed preoperatively, 3 months and 12 months.
 Hospital stays after the procedures will not be considered serious adverse events, unless a
 hospital admission occurs because of a complication of the treatment performed.
Inclusion Criteria:

 1. Male subjects, over 50 years of age at the time of enrollment.

 2. Subjects referred to urology for BPH leading to permanent indwelling bladder catheters
 and are considered poor surgical candidates

 3. Written informed consent to participate in the study.

 4. Ability to comply with the requirements of the study procedures

 Exclusion Criteria:

 1. Previous surgical treatment for BPH

 2. Presence of bladder stones

 3. History of prostate cancer

 4. Prostate size > 150 g

 5. History of urethral stenosis or its management

 6. Known of suspected neurogenic bladder

 7. History of recent hematochezia in the last 3 months

 8. Contraindication to intravascular iodinated contrast such as allergies or significant
 elevated creatinine/renal failure

 9. Uncorrected coagulopathy

 10. Subjects who participated in an active stage of any drug, intervention or treatment
 trial within 30 days of enrollment.

 11. Subjects with preexisting conditions, which, in the opinion of the investigator,
 interfere with the conduct of the study.

 12. Subjects who are uncooperative or cannot follow instructions.

 13. Mental state that may preclude completion of the study procedure or obtention of
 informed consent