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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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