Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
NCT ID: NCT05531240
Last Updated: 2022-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2022-10-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PAE
Prostate Artery Embolization (PAE)
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.
TURP
Transurethral Prostate Resection (TURP)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe atherosclerosis
* Kidney failure
* Urethral stricture
* Active cystitis or prostatitis
* Bladder stone.
* Neurogenic bladder disorder
* Contrast product allergy
45 Years
MALE
No
Sponsors
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Centrallasarettet Västerås
OTHER
Lasarettet i Enköping
OTHER
Sormland County Council, Sweden
OTHER
Helsingborgs Hospital
OTHER
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Abbas Chabok
Role: PRINCIPAL_INVESTIGATOR
CKF Västerås Uppsala university
Locations
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Helsingborgs Hospital
Helsingborg, Region Skånes, Sweden
Mälarsjukhuset
Eskilstuna, Region Sörmland, Sweden
Lasarettet i Enköping
Enköping, Region Uppsala, Sweden
Region Vastmanland Hospital
Västerås, Västmanland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Mats Bläckberg, MD, PhD
Role: primary
Ninos Oussi, MD, PhD
Role: primary
Tammer Hemdan, MD,PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
Related Links
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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
Other Identifiers
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276725
Identifier Type: -
Identifier Source: org_study_id
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