Overview

Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia

Status:
Active, not recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers. The secondary objectives of this study are to: - Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies; - Report the safety of PAE; - Evaluate patient's adherence to medical treatment; - Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.

Phase:

Phase 3

Details

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborator:

Ministry of Health, France