Prostatic Artery Embolization for Benign Prostatic Obstruction

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Hyperplasia Prostatic
• Intervention / Treatment: Procedure: Prostatic Artery Embolization

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostatic Artery Embolization; Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.	Procedure: Prostatic Artery Embolization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to void spontaneously	Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: IPSS; Quality of Life; Complications; benign prostatic hyperplasia; Benign prostatic obstruction; benign prostatic enlargement; prostatic artery embolization; DAN-PSS
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases
• Other Study ID Numbers: H-17000714-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No