Prostatic Artery Embolization for Benign Prostatic Obstruction
|ClinicalTrials.gov Identifier: NCT03099421|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hyperplasia Prostatic Lower Urinary Tract Symptoms Prostatic Diseases Urological Manifestations||Procedure: Prostatic Artery Embolization||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostatic Artery Embolization for Benign Prostatic Obstruction|
|Actual Study Start Date :||March 22, 2017|
|Actual Primary Completion Date :||December 14, 2018|
|Actual Study Completion Date :||December 14, 2018|
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.
- Ability to void spontaneously [ Time Frame: 6 months ]Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months
- IPSS [ Time Frame: 1, 6 months ]International Prostate Symptom Score from 0-35, 35 is most severe symptoms
- QoL [ Time Frame: 1, 6 months ]Quality of Life scored from 0-6, 6 is worst
- IIEF [ Time Frame: 1, 6 months ]International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function
- PV [ Time Frame: 1, 6 months ]Prostate Volume measured by MRI
- PVR [ Time Frame: 1, 6 months ]Post-void residual
- Qmax [ Time Frame: 1, 6 months ]Peak void flow
- PSA [ Time Frame: 1, 6 months ]Prostate-specific antigen
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099421
|Copenhagen, Denmark, 2100|
|Study Chair:||Lars Lönn, Professor||Radiologisk Klinik, Rigshospitalet|