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Completed

NCT Number: NCT01963312

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

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).

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Key information

Conditions

Transurethral Resection of Prostate Artery Embolization Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transarterial Supraselective Embolization of the prostate

Procedure

transurethral resection of the prostate

Procedure

Primary outcomes

  1. Maximum urinary flow (Qmax)

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

  2. Reduction in prostate volume

    Time frame: 12 months

  3. Sexual function

    Time frame: 12 months

    Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention.

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2013
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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