Prostatic Artery Embolization Versus 532 nm Green Light PVP for Catheterized Patients

Phase 4UnknownNCT02006303

Royal Victoria Hospital, Canada73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Green light PVPPROCEDURE

The green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying.

Prostatic artery embolizationPROCEDURE

Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.

Eligibility

Sex: MALEMin age: 40 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ability of the patient to void after removal of the urethral catheter

Time frame: At 24-hours for PVP green light laser and 1-3 weeks for embolization

Secondary Outcomes

Patient subjective satisfaction of both procedures evaluated by the International Prostate Symptom Score (IPSS)

Time frame: At 3, 6, and 12 months post treatment

Degree of prostatic size reduction evaluated by MRI

Time frame: Preoperatively, 3 months and 12 months.

Change in peak flow rate (Qmax) and

Time frame: At 3, 6 and 12 months post treatment

Change in post-void residual urine volume (PVR)

Time frame: At 3, 6, and 12 months

Change in prostate specific antigen (PSA)