NCT02566551

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

Prospective Controlled Randomized Study of Prostatic Arteries Embolization (PAE) vs Transurethral Resection of the Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) Treatment.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Group of Research in Minimally Invasive Techniques · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this prospective randomized controlled study is to compare the improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) and the improvement of QoL assessed by QoL questionnaire in patients undergoing prostatic artery embolization (PAE) to patients of similar characteristics undergoing conventional transurethral resection of the prostate (TURP).

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-05-01
• Completion: 2019-05-01
• First posted: 2015-10-02
• Last updated: 2019-07-12

Locations

1 site across 1 country: Spain