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

Uppsala University104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Transurethral Resection of Prostate Syndrome Prostate Hyperplasia Embolization, Therapeutic

Interventions

Prostate Artery EmbolizationPROCEDURE

Prostate Artery Embolization (PAE) is performed by experienced interventional radiologists. The method involves catheterization of the prostate vessels superselectively with two to three French microcatheters. PAE is performed with microspheres of 250 to 400 µm in size.

Transurethral Prostate Resection (TURP)PROCEDURE

Under general/regional anesthesia, a resectoscope is inserted into the urethra that carries an electric metal loop (monopolar or bipolar diathermy) that is used to cut and extract the prostate tissue.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (4)

Helsingborgs Hospital

Helsingborg, Region Skånes, Sweden

NOT_YET_RECRUITING

Mälarsjukhuset

Eskilstuna, Region Sörmland, Sweden

NOT_YET_RECRUITING

Lasarettet i Enköping

Enköping, Region Uppsala, Sweden

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Improvement of lower urinary tract symptoms

Assess the change in the lower urinary tract symptoms using the International Prostate Symptom Score (IPSS) questionnaire before and after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Time frame: 24 months

Health care costs

Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Time frame: 24 months

Secondary Outcomes

Adverse effects,

Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Time frame: 24 months

Quality of life (Short Form Health Survey [EQ-5D-5L ])

Assess the quality of life after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP). Scored 0-100, where 0 is the lowest and 100 the highest possible quality of life.

Time frame: 24 months

Erectile function

Erectile function using the International Index of Erectile Function (IIEF-5). The possible scores for the IIEF-5 range from 5 to 25, and ED is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

Time frame: 24 months

Prostate-Specific Antigen (PSA)

Assess the change in PSA

Time frame: 24 months

Central Contacts

Emir Majbar, MD

CONTACT

+4621173000 emir.majbar@regionvastmanland.se

Farhood Alamdari, MD, PhD

CONTACT

+4621173000 farhood.alamdari@regionvastmanland.se

Data from ClinicalTrials.gov

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