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Prostatic Artery Embolization for Benign Prostatic Obstruction

NCT ID: NCT03099421

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-22

Study Completion Date

2018-12-14

Brief Summary

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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

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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

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Hyperplasia Prostatic Lower Urinary Tract Symptoms Prostatic Diseases Urological Manifestations

Keywords

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Benign prostatic obstruction benign prostatic enlargement benign prostatic hyperplasia prostatic artery embolization Quality of Life IPSS DAN-PSS Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prostatic Artery Embolization

Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Group Type EXPERIMENTAL

Prostatic Artery Embolization

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Brian Malling

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Lönn, Professor

Role: STUDY_CHAIR

Radiologisk Klinik, Rigshospitalet

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-17000714-1

Identifier Type: -

Identifier Source: org_study_id