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 October 2013 by Fundacion Miguel Servet
Sponsor:
Information provided by (Responsible Party):
Fundacion Miguel Servet
ClinicalTrials.gov Identifier:
NCT01963312
First received: October 11, 2013
Last updated: March 11, 2014
Last verified: October 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Reduction in prostate volume [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  • 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
  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 ClinicalTrials.gov identifier: NCT01963312

Contacts
Contact: Saturnino Napal, MD +34 848422385 saturnino.napal.lecumberri@cfnavarra.es

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

Additional Information:
Publications:
Responsible Party: Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT01963312     History of Changes
Other Study ID Numbers: FMSECUR-11, 2011-002108-34
Study First Received: October 11, 2013
Last Updated: March 11, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014