NCT04398966

Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia

Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients. Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites. Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.

Detailed description

This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.

Conditions

• BPH
• Enlarged Prostate (BPH)
• Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Prostatic Artery Embolization (HydroPearl® compressible microspheres)	Embolic material

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2020-05-22
• Last updated: 2024-05-07
• Results posted: 2024-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study