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Completed

NCT Number: NCT03099421

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.

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Key information

Conditions

Hyperplasia Prostatic Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostatic Artery Embolization

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. IPSS

    Time frame: 1, 6 months

    International Prostate Symptom Score from 0-35, 35 is most severe symptoms

  2. QoL

    Time frame: 1, 6 months

    Quality of Life scored from 0-6, 6 is worst

  3. IIEF

    Time frame: 1, 6 months

    International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function

  4. PV

    Time frame: 1, 6 months

    Prostate Volume measured by MRI

  5. PVR

    Time frame: 1, 6 months

    Post-void residual

  6. Qmax

    Time frame: 1, 6 months

    Peak void flow

  7. PSA

    Time frame: 1, 6 months

    Prostate-specific antigen

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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