Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Fundacion Miguel Servet
Information provided by (Responsible Party):
Fundacion Miguel Servet Identifier:
First received: October 11, 2013
Last updated: November 12, 2015
Last verified: November 2015
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).

Condition Intervention
Transurethral Resection of Prostate
Artery Embolization
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Procedure: Transarterial Supraselective Embolization of the prostate
Procedure: Transurethral Resection of the prostate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Fundacion Miguel Servet:

Primary Outcome Measures:
  • Maximum urinary flow (Qmax) [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
  • Reduction in prostate volume [ Time Frame: 12 months ]
  • Sexual function [ Time Frame: 12 months ]
    Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transarterial Supraselective Embolization
Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm
Procedure: Transarterial Supraselective Embolization of the prostate
Active Comparator: Transurethral Resection
Surgery to remove part of the prostate gland
Procedure: Transurethral Resection of the prostate


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01963312

Contact: Saturnino Napal, MD +34 848422385

Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarre, Spain, 31008
Contact: Ferran Capdevila, PharmD    +34 848422163   
Principal Investigator: Saturnino Napal, MD         
Sub-Investigator: Fermin Urtasun, MD         
Sub-Investigator: Iñigo Insausti, MD         
Sponsors and Collaborators
Fundacion Miguel Servet
Study Director: Saturnino Napal, MD Complejo Hospitalario de Navarra
  More Information

Additional Information:
Responsible Party: Fundacion Miguel Servet Identifier: NCT01963312     History of Changes
Other Study ID Numbers: FMSECUR-11
2011-002108-34 ( EudraCT Number )
Study First Received: October 11, 2013
Last Updated: November 12, 2015

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms processed this record on April 28, 2017