Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral Embolization

Unilateral vs Bilateral Embolization of the Prostate Arteries Clinical Trial

Official title:

Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral Embolization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006431
• Other study ID #: Local/2018
• Status: Completed
• Start date: April 4, 2019
• Est. completion date: April 4, 2020

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries

Description:

Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries.

Method of observation or investigation chosen:

Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.

Origin and nature of the data Patient's medical record: imaging stored in the PACS to confirm unilateral or bilateral embolization, perform measurements of prostate volume, urological medical record to see the effectiveness of embolization in terms of disundation, comfort of life, tolerance of embolization, effectiveness in terms of urination (IPSS score)

Data flow mode:

Data stored in redcap.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 4, 2020
• Est. primary completion date: April 4, 2020
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Elderly patients (>70 years old)

• with contraindications to surgery,

• with a chronic urinary catheterization

Exclusion Criteria:

• <70 years old

• without contraindications to surgery

• without chronic urinary catheterization

Related Conditions & MeSH terms

• Unilateral vs Bilateral Embolization of the Prostate Arteries

Intervention

Other:
• embolization
Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effectiveness of embolization	International prostate score symptomsScore	at one month