- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01963312
Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.
May 4, 2018 updated by: Fundacion Miguel Servet
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Navarre
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Pamplona, Navarre, Spain, 31008
- Complejo Hospitalario de Navarra
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transarterial Supraselective Embolization
Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm
|
|
Active Comparator: Transurethral Resection
Surgery to remove part of the prostate gland
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum urinary flow (Qmax)
Time Frame: 12 months
|
Maximum urinary flow (Qmax) measured prior intervention and one year later
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Prostate Symptom Score (IPSS) measured before and after the intervention
Time Frame: 12 months
|
12 months
|
|
Reduction in prostate volume
Time Frame: 12 months
|
12 months
|
|
Sexual function
Time Frame: 12 months
|
Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Saturnino Napal, MD, Complejo Hospitalario de Navarra
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carnevale 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.
- 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.
- Pisco 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. Erratum In: Radiology. 2013 Sep;268(3):929.
- Mauro 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
October 11, 2013
First Submitted That Met QC Criteria
October 11, 2013
First Posted (Estimate)
October 16, 2013
Study Record Updates
Last Update Posted (Actual)
May 7, 2018
Last Update Submitted That Met QC Criteria
May 4, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMSECUR-11
- 2011-002108-34 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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