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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Transurethral Resection of Prostate, Artery Embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: Transarterial Supraselective Embolization of the prostate
* Procedure: Transurethral Resection of the prostate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transarterial Supraselective Embolization<br>Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm | Procedure: Transarterial Supraselective Embolization of the prostate<br> <br> |
| Active Comparator: Transurethral Resection<br>Surgery to remove part of the prostate gland | Procedure: Transurethral Resection of the prostate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum urinary flow (Qmax) | 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 |  | 12 months | 
| Reduction in prostate volume |  | 12 months | 
| Sexual function | Assessed by International Index of Erectile Function (IIEF) prior and and one year after intervention. | 12 months |