Prostatic Artery Embolization for Benign Prostatic Obstru... | NCT03099421

Studies
Prostatic Artery Embolization for Benign Prostatic Obstruction

NCT03099421

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Dec 19, 2018Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Hyperplasia Prostatic
Lower Urinary Tract Symptoms
Prostatic Diseases
Urological Manifestations

Interventions

Prostatic Artery Embolization

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2017Actual

Primary Completion Date

Dec 14, 2018Actual

Completion Date

Dec 14, 2018Actual

First Submitted Date

Mar 28, 2017

First Submission Date that Met QC Criteria

Mar 28, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2018

Last Update Posted Date

Dec 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 Module

Conditions

Hyperplasia Prostatic
Lower Urinary Tract Symptoms
Prostatic Diseases
Urological Manifestations

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostatic Artery Embolization	Experimental	Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.	Procedure: Prostatic Artery Embolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to void spontaneously	Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months	6 months

Secondary Outcomes

Measure	Description	Time Frame
IPSS	International Prostate Symptom Score from 0-35, 35 is most severe symptoms	1, 6 months
QoL	Quality of Life scored from 0-6, 6 is worst

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Lönn, Professor	Radiologisk Klinik, Rigshospitalet	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia
D059411	Lower Urinary Tract Symptoms
D011469	Prostatic Diseases
D020924	Urological Manifestations

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided