Clinical trial NCT01963312: 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
Overall status: COMPLETED
Phase: NA
Conditions: Transurethral Resection of Prostate
Artery Embolization
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 81
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Maximum urinary flow (Qmax)
timeFrame: 12 months
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS) measured before and after the intervention
timeFrame: 12 months
measure: Reduction in prostate volume
timeFrame: 12 months
measure: Sexual function
timeFrame: 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarre
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Saturnino Napal, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.