Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms.

Benign Prostatic Hyperplasia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963312
• Other study ID #: FMSECUR-11
• Secondary ID: 2011-002108-34
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artery Embolization
• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia
• Transurethral Resection of Prostate

Intervention

Procedure:
• Transarterial Supraselective Embolization of the prostate

• Transurethral Resection of the prostate

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarre

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum urinary flow (Qmax)	Maximum urinary flow (Qmax) measured prior intervention and one year later	12 months
Secondary	International Prostate Symptom Score (IPSS) measured before and after the intervention		12 months
Secondary	Reduction in prostate volume		12 months
Secondary	Sexual function	Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.	12 months

External Links

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