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

Fundacion Miguel Servet

Status

Completed

Conditions

Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia

Artery Embolization

Transurethral Resection of Prostate

Treatments

Procedure: Transurethral Resection of the prostate

Procedure: Transarterial Supraselective Embolization of the prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT01963312

2011-002108-34 (EudraCT Number)

FMSECUR-11

Details and patient eligibility

About

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).

Enrollment

81 patients

Sex

Male

Ages

60+ years old

Volunteers

No Healthy Volunteers

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