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Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.

NCT02566551 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-12

No results posted yet for this study

Summary

The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) and the improvement of QoL, in patients undergoing prostatic artery embolization (PAE) or conventional transurethral resection of the prostate (TURP).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

PROCEDURE

PAE

Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.

DEVICE

Gelatin microspheres

Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol

PROCEDURE

TURP

Bipolar transurethral resection of the prostate

DEVICE

Bipolar electrosurgery generator

A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)

Sponsors & Collaborators

  • Hospital Clínico Universitario Lozano Blesa

    collaborator OTHER

  • Universidad de Zaragoza

    collaborator OTHER

  • Group of Research in Minimally Invasive Techniques

    lead OTHER

Principal Investigators

  • Miguel A De Gregorio, PhD · University of Zaragoza. Chairman of Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-05-31
Completion
2019-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566551 on ClinicalTrials.gov