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

Not Applicable

Completed

• Conditions: Artery Embolization; Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Transurethral Resection of Prostate
• Interventions: Procedure: Transarterial Supraselective Embolization of the prostate; Procedure: Transurethral Resection of the prostate

• Registration Number: NCT01963312
• Lead Sponsor: Fundacion Miguel Servet

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Start: 2014-03
• Primary Completion: 2018-04
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transarterial Supraselective Embolization	Transarterial Supraselective Embolization of the prostate	Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm
Transurethral Resection	Transurethral Resection of the prostate	Surgery to remove part of the prostate gland

Primary Outcome Measures

Name	Time	Method
Maximum urinary flow (Qmax)	12 months	Maximum urinary flow (Qmax) measured prior intervention and one year later

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarre, Spain