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

May 4, 2018 updated by: Fundacion Miguel Servet

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Complejo Hospitalario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum urinary flow (Qmax)
Time Frame: 12 months
Maximum urinary flow (Qmax) measured prior intervention and one year later
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score (IPSS) measured before and after the intervention
Time Frame: 12 months
12 months
Reduction in prostate volume
Time Frame: 12 months
12 months
Sexual function
Time Frame: 12 months
Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Study Director: Saturnino Napal, MD, Complejo Hospitalario de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMSECUR-11
  • 2011-002108-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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