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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01963312

Enrollment

Registered

2013-10-16

Start date

2014-03-31

Completion date

2018-05-31

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

PROCEDURETransarterial Supraselective Embolization of the prostate

PROCEDURETransurethral Resection of the prostate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum urinary flow (Qmax)	12 months	Maximum urinary flow (Qmax) measured prior intervention and one year later

Secondary

Measure	Time frame	Description
International Prostate Symptom Score (IPSS) measured before and after the intervention	12 months	—
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026