Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
1 other identifier
interventional
104
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
October 2, 2026
September 1, 2026
5.2 years
May 30, 2022
September 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Adverse effects,
24 months
Quality of life (Short Form Health Survey [EQ-5D-5L ])
24 months
Erectile function
24 months
Prostate-Specific Antigen (PSA)
24 months
Study Arms (2)
PAE
EXPERIMENTALProstate Artery Embolization (PAE)
TURP
ACTIVE COMPARATORTransurethral Prostate Resection (TURP)
Interventions
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.
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
You may qualify if:
- Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
- IPSS\>=12
- Prostate volume \[40-100\] ml measured via transrectal ultrasound
- Peak flow rate (Qmax) \<= 15 ml / s,
- Verified obstruction by urodynamic studies (cystometry)
- Surgery not contraindicated
You may not qualify if:
- known prostate or bladder cancer
- Severe atherosclerosis
- Kidney failure eGFR \< 30
- Urethral stricture
- Active cystitis or prostatitis
- Bladder stone.
- Neurogenic bladder disorder
- known allergy to iodinated contrast medium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Centrallasarettet Västeråscollaborator
- Sormland County Council, Swedencollaborator
- Region Stockholmcollaborator
- Lasarettet i Enköpingcollaborator
Study Sites (4)
Helsingborgs Hospital
Helsingborg, Region Skånes, 252 23, Sweden
Mälarsjukhuset
Eskilstuna, Region Sörmland, 633 49, Sweden
Lasarettet i Enköping
Enköping, Region Uppsala, 745 38, Sweden
Region Vastmanland Hospital
Västerås, Västmanland County, 721 89, Sweden
Related Publications (5)
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.
PMID: 1714529BACKGROUNDHunter 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.
PMID: 7539561BACKGROUNDBarry 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.
PMID: 1279218BACKGROUNDYoung 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.
PMID: 32027007BACKGROUNDCarnevale 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.
PMID: 19908092BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abbas Chabok
CKF Västerås Uppsala university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 30, 2022
First Posted
September 7, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
October 2, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR