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

NCT01963312 | Completed

• 2 other identifiers: FMSECUR-112011-002108-34
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Maximum urinary flow (Qmax)

  Maximum urinary flow (Qmax) measured prior intervention and one year later

  12 months

Secondary Outcomes (3)

• International Prostate Symptom Score (IPSS) measured before and after the intervention

  12 months

• Reduction in prostate volume

  12 months

• Sexual function

  12 months

Study Arms (2)

Transarterial Supraselective Embolization

EXPERIMENTAL

Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm

Procedure: Transarterial Supraselective Embolization of the prostate

Transurethral Resection

ACTIVE COMPARATOR

Surgery to remove part of the prostate gland

Procedure: Transurethral Resection of the prostate

Interventions

Transarterial Supraselective Embolization of the prostate PROCEDURE

Transarterial Supraselective Embolization

Transurethral Resection of the prostate PROCEDURE

Transurethral Resection

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (4)

• 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.

  PMID: 10877424 BACKGROUND

• 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.

  PMID: 19908092 BACKGROUND

• 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.

  PMID: 23204546 BACKGROUND

• 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.

  PMID: 18309010 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Saturnino Napal, MD

  Complejo Hospitalario de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 16, 2013
• Study Start: March 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

ES (1)