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Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia

NCT02074644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-02-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether prostatic arterial embolization (PAE) compared is an effective and safe treatment for benign prostatic hyperplasia in patients with severe lower urinary tract symptoms not adequately controlled by medical therapy with alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6 months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered the possibility of performing PAE after 6 months. All patients may participate on an optional 6-months extension study.

Conditions

  • Prostatic Hyperplasia, Benign
  • Prostatic Hypertrophy, Benign
  • Genital Diseases, Male
  • Lower Urinary Tract Symptoms
  • Prostatic Diseases

Interventions

PROCEDURE

Prostatic Arterial Embolization

The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. Bead Block 300-500 or PVA 100+200 micra particles are slowly injected under fluoroscopic control until the end point is reached. Embolization is considered finished when there is "near stasis" in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification checked in both oblique and AP views. Upon finishing the embolization of the left prostatic arteries, the right prostatic arteries are embolized in the same way.

PROCEDURE

Sham procedure

The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. The catheter is removed and no particles are injected.

Sponsors & Collaborators

  • João Martins Pisco

    lead OTHER

Principal Investigators

  • João M Pisco, M.D,. Ph.D. · Hospital de Saint Louis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-02
Primary Completion
2019-03-03
Completion
2019-03-03

Countries

  • Portugal

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 NCT02074644 on ClinicalTrials.gov