Prostatic Artery Embolization for Benign Prostatic Obstruction

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Prostatic Artery Embolization for Benign Prostatic Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099421
• Other study ID #: H-17000714-1
• Status: Completed
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: December 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Hyperplasia Prostatic
• Lower Urinary Tract Symptoms
• Prostatic Diseases
• Urological Manifestations

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to void spontaneously	Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months	6 months
Secondary	IPSS	International Prostate Symptom Score from 0-35, 35 is most severe symptoms	1, 6 months
Secondary	QoL	Quality of Life scored from 0-6, 6 is worst	1, 6 months
Secondary	IIEF	International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function	1, 6 months
Secondary	PV	Prostate Volume measured by MRI	1, 6 months
Secondary	PVR	Post-void residual	1, 6 months
Secondary	Qmax	Peak void flow	1, 6 months
Secondary	PSA	Prostate-specific antigen	1, 6 months