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

Study Overview
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Brief Summary
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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.

Official Title
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Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics

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

Intervention / Treatment
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* Procedure: Prostate Artery Embolization
* Procedure: Transurethral Prostate Resection (TURP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAE<br>Prostate Artery Embolization (PAE) | Procedure: Prostate Artery Embolization<br>* 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.<br>|
| Active Comparator: TURP<br>Transurethral Prostate Resection (TURP) | Procedure: Transurethral Prostate Resection (TURP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 months | 
| Health care costs | Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects, | Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP) | 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. | 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). | 24 months | 
| Prostate-Specific Antigen (PSA) | Assess the change in PSA | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate embolisation, PAE