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

Prostate Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531240
• Other study ID #: 276725
• Status: Recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: Uppsala University
• Contact: Emir Majbar, MD
• Phone: +4621173000
• Email: emir.majbar[@]regionvastmanland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolization, Therapeutic
• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia
• Transurethral Resection of Prostate Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Lasarettet i Enköping	Enköping	Region Uppsala
Sweden	Mälarsjukhuset	Eskilstuna	Region Sörmland
Sweden	Helsingborgs Hospital	Helsingborg	Region Skånes
Sweden	Region Vastmanland Hospital	Västerås	Västmanland

Sponsors (5)

Lead Sponsor	Collaborator
Uppsala University	Centrallasarettet Västerås, Helsingborgs Hospital, Lasarettet i Enköping, Sormland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

Abt D, Hechelhammer L, Müllhaupt G, Markart S, Güsewell 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. — View Citation

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. — View Citation

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, Société Française 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. Review. — View Citation

NICE Guidance - Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia: © 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse effects,	Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)	24 months
Secondary	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
Secondary	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
Secondary	Prostate-Specific Antigen (PSA)	Assess the change in PSA	24 months

External 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