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

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

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 Overview

• Status: Recruiting
• Conditions: Prostate Hyperplasia; Embolization, Therapeutic; Transurethral Resection of Prostate Syndrome
• Intervention / Treatment: Procedure: Prostate Artery Embolization; Procedure: Transurethral Prostate Resection (TURP)

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emir Majbar, MD; Phone Number: +4621173000; Email: emir.majbar@regionvastmanland.se
• Study Contact Backup: Name: Farhood Alamdari, MD, PhD; Phone Number: +4621173000; Email: farhood.alamdari@regionvastmanland.se

Study Locations

• Sweden
  • Region Skånes
    • Helsingborg, Region Skånes, Sweden, 252 23
      • Not yet recruiting
      • Helsingborgs Hospital
      • Contact: Mats Bläckberg, MD, PhD; Phone Number: +46 424061000
  • Region Sörmland
    • Eskilstuna, Region Sörmland, Sweden, 633 49
      • Not yet recruiting
      • Mälarsjukhuset
      • Contact: Ninos Oussi, MD, PhD; Phone Number: +46 16103000
  • Region Uppsala
    • Enköping, Region Uppsala, Sweden, 745 38
      • Not yet recruiting
      • Lasarettet i Enkoping
      • Contact: Tammer Hemdan, MD,PhD; Phone Number: +46 17141 80 00
  • Västmanland
    • Västerås, Västmanland, Sweden, 721 89
      • Recruiting
      • Region Vastmanland Hospital
      • Contact: Emir Majbar, MD; Phone Number: +46 21173000; Email: emir.majbar@regionvastmanland.se
      • Contact: Farhood Alamdari, MD, PhD; Phone Number: +46 21173000; Email: farhood.alamdari@regionvastmanland.se
      • Principal Investigator: Abbas Chabok, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAE; Prostate Artery Embolization (PAE)	Procedure: Prostate Artery Embolization; 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.
Active Comparator: TURP; Transurethral Prostate Resection (TURP)	Procedure: Transurethral Prostate Resection (TURP); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Helsingborgs Hospital; Sormland County Council, Sweden; Centrallasarettet Västerås; Lasarettet i Enköping
• Investigators: Principal Investigator: Abbas Chabok, CKF Västerås Uppsala university

Publications and helpful links

General Publications

• Abt D, Hechelhammer L, Mullhaupt G, Markart S, Gusewell S, Kessler TM, Schmid HP, Engeler DS, Mordasini L. Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial. BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338.
• Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
• Gao YA, Huang Y, Zhang R, Yang YD, Zhang Q, Hou M, Wang Y. Benign prostatic hyperplasia: prostatic arterial embolization versus transurethral resection of the prostate--a prospective, randomized, and controlled clinical trial. Radiology. 2014 Mar;270(3):920-8. doi: 10.1148/radiol.13122803. Epub 2013 Nov 13.
• Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
• Hunter DJ, McKee M, Black NA, Sanderson CF. Health status and quality of life of British men with lower urinary tract symptoms: results from the SF-36. Urology. 1995 Jun;45(6):962-71. doi: 10.1016/s0090-4295(99)80116-2.
• Young S, Golzarian J. Prostate embolization: patient selection, clinical management and results. CVIR Endovasc. 2019 Jan 18;2(1):7. doi: 10.1186/s42155-019-0049-1.
• Burnett AL, Wein AJ. Benign prostatic hyperplasia in primary care: what you need to know. J Urol. 2006 Mar;175(3 Pt 2):S19-24. doi: 10.1016/S0022-5347(05)00310-1.
• Pinheiro LC, Martins Pisco J. Treatment of benign prostatic hyperplasia. Tech Vasc Interv Radiol. 2012 Dec;15(4):256-60. doi: 10.1053/j.tvir.2012.09.004.
• Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.
• McWilliams JP, Bilhim TA, Carnevale FC, Bhatia S, Isaacson AJ, Bagla S, Sapoval MR, Golzarian J, Salem R, McClure TD, Kava BR, Spies JB, Sabharwal T, McCafferty I, Tam AL. Society of Interventional Radiology Multisociety Consensus Position Statement on Prostatic Artery Embolization for Treatment of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: From the Society of Interventional Radiology, the Cardiovascular and Interventional Radiological Society of Europe, Societe Francaise de Radiologie, and the British Society of Interventional Radiology: Endorsed by the Asia Pacific Society of Cardiovascular and Interventional Radiology, Canadian Association for Interventional Radiology, Chinese College of Interventionalists, Interventional Radiology Society of Australasia, Japanese Society of Interventional Radiology, and Korean Society of Interventional Radiology. J Vasc Interv Radiol. 2019 May;30(5):627-637.e1. doi: 10.1016/j.jvir.2019.02.013. Epub 2019 Mar 27. No abstract available.
• NICE Guidance - Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia: (c) NICE (2018) Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia. BJU Int. 2018 Jul;122(1):11-12. doi: 10.1111/bju.14404. No abstract available.

Helpful Links

• Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO) 2021. I: European Association of Urology Guidelines 2021 Edition

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: PAE; Prostate embolisation
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 276725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No