Hyperplasia ProstaticNCT03099421
Prostatic Artery Embolization for Benign Prostatic Obstruction
A study testing Prostatic Artery Embolization in people with Hyperplasia Prostatic and Lower Urinary Tract Symptoms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hyperplasia Prostatic, Lower Urinary Tract Symptoms, Prostatic Diseases
- What is being tested?
- Prostatic Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2017to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- Coagulation disturbances
- Severe atheromatous or tortuosity of arteries
- Allergy to contrast medium
- Unable to undergo MR imaging
- Urological malignancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Prostatic Artery Embolization
- Keywords
- Benign prostatic obstruction, benign prostatic enlargement, benign prostatic hyperplasia, prostatic artery embolization, Quality of Life, IPSS, DAN-PSS, Complications
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Prostatic Diseases, Urological Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Artery Embolization | Experimental | Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume. Receives: Procedure: Prostatic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to void spontaneously
Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months
Measured: 6 months
Secondary outcomes (7)
IPSS
International Prostate Symptom Score from 0-35, 35 is most severe symptoms
Measured: 1, 6 months
QoL
Quality of Life scored from 0-6, 6 is worst
Measured: 1, 6 months
IIEF
International Index of Erectile Function scored from 0-25, where higher scores represents better erectile function
Measured: 1, 6 months
PV
Prostate Volume measured by MRI
Measured: 1, 6 months
PVR
Post-void residual
Measured: 1, 6 months
Qmax
Peak void flow
Measured: 1, 6 months
PSA
Prostate-specific antigen
Measured: 1, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start22 Mar 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperplasia ProstaticStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Malling, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Lönn, Professor, Study chair, Radiologisk Klinik, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099421
- Sponsor's protocol ID
- H-17000714-1
- Status last verified
- Dec 2018
- First submitted
- 28 Mar 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization for Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT03099421
- Acronym / sponsor ID
- H-17000714-1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostatic Artery Embolization | Experimental | Procedure: Prostatic Artery EmbolizationEmbolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Bladder dysfunction(and known neurological conditions affecting bladder function)
- Urethral strictures
- Bladder neck contracture
- Known sphincter anomalies
- Big bladder diverticulum or stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostatic Artery EmbolizationThe 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. | Procedure or surgery | Prostatic Artery Embolization |
Primary outcome
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
7 secondary outcomes
IPSS
Time frame: 1, 6 months
QoL
Time frame: 1, 6 months
IIEF
Time frame: 1, 6 months
PV
Time frame: 1, 6 months
PVR
Time frame: 1, 6 months
Qmax
Time frame: 1, 6 months
PSA
Time frame: 1, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Lönn, Professor study chair
Radiologisk Klinik, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatic Artery Embolization in people with Hyperplasia Prostatic and Lower Urinary Tract Symptoms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to void spontaneously (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.