Transurethral Resection of ProstateNCT01963312
Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.
A study testing Transarterial Supraselective Embolization of the prostate and Transurethral Resection of the prostate in people with Transurethral Resection of Prostate and Artery Embolization, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Transurethral Resection of Prostate, Artery Embolization, Benign Prostatic Hyperplasia
- What is being tested?
- Transarterial Supraselective Embolization of the prostate and Transurethral Resection of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to May 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms
- Refractory to medical treatment for at least 6 months
- Qmax (maximum urinary flow) less than 10 mL/second
Who cannot join
- Patients not candidates for transurethral resection of the prostate (TURP)
- Advanced atherosclerosis and tortuosity of the iliac arteries
- No visualization of the prostatic artery CT angiography study
- Urethral stenosis, detrusor failure or neurogenic bladder
- Glomerular filtration < 30 mL/min
- Presence of malignant tumor
- History of allergy to iodinated contrast
- Patients with any other medical or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Clinical Trial to Compare Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate Compared Versus the Transurethral Resection of the Prostate to Treat the Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.
The purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
- Conditions
- Transurethral Resection of Prostate, Artery Embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- Being tested
- Transarterial Supraselective Embolization of the prostate, Transurethral Resection of the prostate
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial Supraselective Embolization of the prostateProcedure or surgery
Transurethral Resection of the prostateProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transarterial Supraselective Embolization | Experimental | Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm Receives: Procedure: Transarterial Supraselective Embolization of the prostate |
| Transurethral Resection | Active comparator | Surgery to remove part of the prostate gland Receives: Procedure: Transurethral Resection of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum urinary flow (Qmax)
Maximum urinary flow (Qmax) measured prior intervention and one year later
Measured: 12 months
Secondary outcomes (3)
International Prostate Symptom Score (IPSS) measured before and after the intervention
Measured: 12 months
Reduction in prostate volume
Measured: 12 months
Sexual function
Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transurethral Resection of ProstateStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saturnino Napal, MD, Study director, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963312
- Sponsor's protocol ID
- FMSECUR-11
- Other IDs
- 2011-002108-34
- Status last verified
- May 2018
- First submitted
- 11 Oct 2013
- Last updated
- 7 May 2018
- Results posted
- No
Publications
DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol. 2000 Jun;11(6):767-70. doi: 10.1016/s1051-0443(07)61638-8. No abstract available.
PubMed 10877424Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.
PubMed 19908092Pisco J, Campos Pinheiro L, Bilhim T, Duarte M, Rio Tinto H, Fernandes L, Vaz Santos V, Oliveira AG. Prostatic arterial embolization for benign prostatic hyperplasia: short- and intermediate-term results. Radiology. 2013 Feb;266(2):668-77. doi: 10.1148/radiol.12111601. Epub 2012 Nov 30.
PubMed 23204546Mauro MA. Can hyperplastic prostate follow uterine fibroids and be managed with transcatheter arterial embolization? Radiology. 2008 Mar;246(3):657-8. doi: 10.1148/radiol.2463071721.
PubMed 18309010
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial to Compare Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate Compared Versus the Transurethral Resection of the Prostate to Treat the Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.
- ClinicalTrials.gov ID
- NCT01963312
- Acronym / sponsor ID
- FMSECUR-11
- Conditions
- Transurethral Resection of Prostate, Artery Embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 16 Oct 2013 (estimated)
- 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 purpose of this study is to determine whether the transarterial supraselective embolization (TSE) is a technique as effective as transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transarterial Supraselective Embolization | Experimental | Procedure: Transarterial Supraselective Embolization of the prostateTransarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm |
| Transurethral Resection | Active comparator | Procedure: Transurethral Resection of the prostateSurgery to remove part of the prostate gland |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of benign prostatic hyperplasia with moderate or severe obstructive lower urinary tract symptoms
- Refractory to medical treatment for at least 6 months
- Qmax (maximum urinary flow) less than 10 mL/second
Key exclusion criteria (8 listed)
- Patients not candidates for transurethral resection of the prostate (TURP)
- Advanced atherosclerosis and tortuosity of the iliac arteries
- No visualization of the prostatic artery CT angiography study
- Urethral stenosis, detrusor failure or neurogenic bladder
- Glomerular filtration < 30 mL/min
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 |
|---|---|---|
| Transarterial Supraselective Embolization of the prostate | Procedure or surgery | Transarterial Supraselective Embolization |
| Transurethral Resection of the prostate | Procedure or surgery | Transurethral Resection |
Primary outcome
Maximum urinary flow (Qmax)
Time frame: 12 months
Maximum urinary flow (Qmax) measured prior intervention and one year later
3 secondary outcomes
International Prostate Symptom Score (IPSS) measured before and after the intervention
Time frame: 12 months
Reduction in prostate volume
Time frame: 12 months
Sexual function
Time frame: 12 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 7 May 2018.
- Background: PubMed 10877424DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol. 2000 Jun;11(6):767-70. doi: 10.1016/s1051-0443(07)61638-8. No abstract available.
- Background: PubMed 19908092Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.
- Background: PubMed 23204546Pisco J, Campos Pinheiro L, Bilhim T, Duarte M, Rio Tinto H, Fernandes L, Vaz Santos V, Oliveira AG. Prostatic arterial embolization for benign prostatic hyperplasia: short- and intermediate-term results. Radiology. 2013 Feb;266(2):668-77. doi: 10.1148/radiol.12111601. Epub 2012 Nov 30.
- Background: PubMed 18309010Mauro MA. Can hyperplastic prostate follow uterine fibroids and be managed with transcatheter arterial embolization? Radiology. 2008 Mar;246(3):657-8. doi: 10.1148/radiol.2463071721.
- Related InfoLink provided by the sponsor.
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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.
Saturnino Napal, MD study director
Complejo Hospitalario de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial Supraselective Embolization of the prostate and Transurethral Resection of the prostate in people with Transurethral Resection of Prostate and Artery Embolization, run by Fundacion Miguel Servet at 1 site in Spain.
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 8 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 7 May 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 Spain. 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?
Maximum urinary flow (Qmax) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963312, which also lists 4 linked publications.
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 7 May 2018.