Prostatic Artery Embolization for Benign Prostatic Obstruction

Rigshospitalet, Denmark11 enrolled

Overview

The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.

This is a prospective study investigating the safety and efficacy of PAE for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. It may form the grounding for further research in the shape of a larger randomised clinical trial. Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS 6 months post-procedure. 1, and 6 months follow-up. Main outcome Ability to void after removal of indwelling catheter Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperplasia Prostatic Lower Urinary Tract Symptoms Prostatic Diseases Urological Manifestations

Interventions

Prostatic Artery EmbolizationPROCEDURE

The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or * Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment * Unsuitable for TURP or refuse surgery Exclusion Criteria: * Bladder dysfunction(and known neurological conditions affecting bladder function) * Urethral strictures * Bladder neck contracture * Known sphincter anomalies * Big bladder diverticulum or stones * Kidney insufficiency (eGFR \< 45) * Coagulation disturbances * Severe atheromatous or tortuosity of arteries * Allergy to contrast medium * Unable to undergo MR imaging * Urological malignancy

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Ability to void spontaneously

Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months

Time frame: 6 months

Secondary Outcomes

IPSS

International Prostate Symptom Score from 0-35, 35 is most severe symptoms

Time frame: 1, 6 months

QoL

Quality of Life scored from 0-6, 6 is worst

Time frame: 1, 6 months

IIEF

International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function

Time frame: 1, 6 months

Prostate Volume measured by MRI

Time frame: 1, 6 months

PVR

Post-void residual

Time frame: 1, 6 months

Qmax

Peak void flow

Time frame: 1, 6 months

PSA

Prostate-specific antigen

Time frame: 1, 6 months

Data from ClinicalTrials.gov

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