NCT03099421

Prostatic Artery Embolization for Benign Prostatic Obstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-22
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2017-04-04
• Last updated: 2018-12-19

Locations

1 site across 1 country: Denmark