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Prostatic Artery Embolization for Benign Prostatic Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099421
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Malling, Rigshospitalet, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperplasia Prostatic Lower Urinary Tract Symptoms Prostatic Diseases Urological Manifestations Procedure: Prostatic Artery Embolization Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099421


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Lars Lönn, Professor Radiologisk Klinik, Rigshospitalet
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Responsible Party: Brian Malling, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03099421    
Other Study ID Numbers: H-17000714-1
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Malling, Rigshospitalet, Denmark:
Benign prostatic obstruction
benign prostatic enlargement
benign prostatic hyperplasia
prostatic artery embolization
Quality of Life
IPSS
DAN-PSS
Complications
Additional relevant MeSH terms:
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Prostatic Diseases
Hyperplasia
Lower Urinary Tract Symptoms
Urological Manifestations
Pathologic Processes