Prostatic Artery Embolization for Benign Prostatic Obstruction

Not Applicable

Completed

• Conditions: Hyperplasia Prostatic; Lower Urinary Tract Symptoms; Prostatic Diseases; Urological Manifestations
• Interventions: Procedure: Prostatic Artery Embolization

• Registration Number: NCT03099421
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-03-22
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Status Verified: 2018-12
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostatic Artery Embolization	Prostatic Artery Embolization	Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Primary Outcome Measures

Name	Time	Method
Ability to void spontaneously	6 months	Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months

Secondary Outcome Measures

Name	Time	Method
PV	1, 6 months	Prostate Volume measured by MRI
Qmax	1, 6 months	Peak void flow
PVR	1, 6 months	Post-void residual
QoL	1, 6 months	Quality of Life scored from 0-6, 6 is worst
PSA	1, 6 months	Prostate-specific antigen
IIEF	1, 6 months	International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function
IPSS	1, 6 months	International Prostate Symptom Score from 0-35, 35 is most severe symptoms

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark