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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-05-31

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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transarterial Supraselective Embolization

Transarterial supraselective embolization of prostatic arteria with Bead Block 300-500 μm

Group Type EXPERIMENTAL

Transarterial Supraselective Embolization of the prostate

Intervention Type PROCEDURE

Transurethral Resection

Surgery to remove part of the prostate gland

Group Type ACTIVE_COMPARATOR

Transurethral Resection of the prostate

Intervention Type PROCEDURE

Interventions

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Transarterial Supraselective Embolization of the prostate

Intervention Type PROCEDURE

Transurethral Resection of the prostate

Intervention Type PROCEDURE

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

Minimum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No