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

Urinary Retention Clinical Trial

Official title: Prostatic Artery Embolization Versus 532 nm Green Light Laser Photoselective Vaporization of the Prostate for Treating Catheter-Dependent Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Clinical Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Retention

• NCT number: NCT02006303
• Study type: Interventional
• Source: Royal Victoria Hospital, Canada
• Contact: Mostafa Elhilali, MD,PhD,FRCSC
• Phone: 1- 514- 843-1516
• Email: mostafa.elhilali@muhc.mcgill.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2013
• Completion date: December 2015