Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)

Uppsala University

Status: Enrolling

Conditions: Prostate Hyperplasia; Embolization, Therapeutic; Transurethral Resection of Prostate Syndrome

Treatments: Procedure: Prostate Artery Embolization; Procedure: Transurethral Prostate Resection (TURP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05531240

276725

Details and patient eligibility

About

This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.

The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.

Enrollment: 104 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
• IPSS>=8
• Prostate volume [40-80] ml measured via transrectal ultrasound
• Peak flow rate (Qmax) <= 15 ml / s,
• Verified obstruction by urodynamic studies (cystometry)
• Surgery not contraindicated

Exclusion criteria

• Prostate cancer
• Severe atherosclerosis
• Kidney failure
• Urethral stricture
• Active cystitis or prostatitis
• Bladder stone.
• Neurogenic bladder disorder
• Contrast product allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

PAE

Experimental group

Description:

Prostate Artery Embolization (PAE)

Treatment:

Procedure: Prostate Artery Embolization

TURP

Active Comparator group

Description:

Transurethral Prostate Resection (TURP)

Treatment:

Procedure: Transurethral Prostate Resection (TURP)