Back to resultsClinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.
Primary Purpose
Transurethral Resection of Prostate, Artery Embolization, Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transarterial Supraselective Embolization of the prostate
Transurethral Resection of the prostate
Sponsored by
About this trial
This is an interventional treatment trial for Transurethral Resection of Prostate
Eligibility Criteria
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
Sites / Locations
- Complejo Hospitalario de Navarra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transarterial Supraselective Embolization
Transurethral Resection
Arm Description
Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm
Surgery to remove part of the prostate gland
Outcomes
Primary Outcome Measures
Maximum urinary flow (Qmax)
Maximum urinary flow (Qmax) measured prior intervention and one year later
Secondary Outcome Measures
International Prostate Symptom Score (IPSS) measured before and after the intervention
Reduction in prostate volume
Sexual function
Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01963312
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transurethral Resection of Prostate, Artery Embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transarterial Supraselective Embolization
Arm Type
Experimental
Arm Description
Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm
Arm Title
Transurethral Resection
Arm Type
Active Comparator
Arm Description
Surgery to remove part of the prostate gland
Intervention Type
Procedure
Intervention Name(s)
Transarterial Supraselective Embolization of the prostate
Intervention Type
Procedure
Intervention Name(s)
Transurethral Resection of the prostate
Primary Outcome Measure Information:
Title
Maximum urinary flow (Qmax)
Description
Maximum urinary flow (Qmax) measured prior intervention and one year later
Time Frame
12 months
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) measured before and after the intervention
Time Frame
12 months
Title
Reduction in prostate volume
Time Frame
12 months
Title
Sexual function
Description
Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saturnino Napal, MD
Organizational Affiliation
Complejo Hospitalario de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
10877424
Citation
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.
Results Reference
background
PubMed Identifier
19908092
Citation
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.
Results Reference
background
PubMed Identifier
23204546
Citation
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.
Results Reference
background
PubMed Identifier
18309010
Citation
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.
Results Reference
background
Links:
URL
http://www.navarrabiomed.es
Description
Related Info
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Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.
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