search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Prostate Artery Embolization
Transurethral Prostate Resection (TURP)
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transurethral Resection of Prostate Syndrome focused on measuring Prostate embolisation, PAE

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsingborgs Hospital
  • Mälarsjukhuset
  • Lasarettet i Enköping
  • Region Vastmanland HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PAE

TURP

Arm Description

Prostate Artery Embolization (PAE)

Transurethral Prostate Resection (TURP)

Outcomes

Primary Outcome Measures

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)
Health care costs
Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)

Secondary Outcome Measures

Adverse effects,
Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
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.
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).
Prostate-Specific Antigen (PSA)
Assess the change in PSA

Full Information

First Posted
May 30, 2022
Last Updated
September 30, 2022
Sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås, Lasarettet i Enköping, Sormland County Council, Sweden, Helsingborgs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05531240
Brief Title
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
Official Title
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Centrallasarettet Västerås, Lasarettet i Enköping, Sormland County Council, Sweden, Helsingborgs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transurethral Resection of Prostate Syndrome, Prostate Hyperplasia, Embolization, Therapeutic
Keywords
Prostate embolisation, PAE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAE
Arm Type
Experimental
Arm Description
Prostate Artery Embolization (PAE)
Arm Title
TURP
Arm Type
Active Comparator
Arm Description
Transurethral Prostate Resection (TURP)
Intervention Type
Procedure
Intervention Name(s)
Prostate Artery Embolization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transurethral Prostate Resection (TURP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of lower urinary tract symptoms
Description
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)
Time Frame
24 months
Title
Health care costs
Description
Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Adverse effects,
Description
Assess the adverse effects after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Time Frame
24 months
Title
Quality of life (Short Form Health Survey [EQ-5D-5L ])
Description
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.
Time Frame
24 months
Title
Erectile function
Description
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).
Time Frame
24 months
Title
Prostate-Specific Antigen (PSA)
Description
Assess the change in PSA
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emir Majbar, MD
Phone
+4621173000
Email
emir.majbar@regionvastmanland.se
First Name & Middle Initial & Last Name or Official Title & Degree
Farhood Alamdari, MD, PhD
Phone
+4621173000
Email
farhood.alamdari@regionvastmanland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbas Chabok
Organizational Affiliation
CKF Västerås Uppsala university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsingborgs Hospital
City
Helsingborg
State/Province
Region Skånes
ZIP/Postal Code
252 23
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Bläckberg, MD, PhD
Phone
+46 424061000
Facility Name
Mälarsjukhuset
City
Eskilstuna
State/Province
Region Sörmland
ZIP/Postal Code
633 49
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ninos Oussi, MD, PhD
Phone
+46 16103000
Facility Name
Lasarettet i Enköping
City
Enköping
State/Province
Region Uppsala
ZIP/Postal Code
745 38
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammer Hemdan, MD,PhD
Phone
+46 17141 80 00
Facility Name
Region Vastmanland Hospital
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
721 89
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emir Majbar, MD
Phone
+46 21173000
Email
emir.majbar@regionvastmanland.se
First Name & Middle Initial & Last Name & Degree
Farhood Alamdari, MD, PhD
Phone
+46 21173000
Email
farhood.alamdari@regionvastmanland.se
First Name & Middle Initial & Last Name & Degree
Abbas Chabok, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
1714529
Citation
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.
Results Reference
background
PubMed Identifier
7539561
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. doi: 10.1016/s0090-4295(99)80116-2.
Results Reference
background
PubMed Identifier
1279218
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. doi: 10.1016/s0022-5347(17)36966-5.
Results Reference
background
PubMed Identifier
32027007
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.
Results Reference
background
PubMed Identifier
16458735
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. doi: 10.1016/S0022-5347(05)00310-1.
Results Reference
background
PubMed Identifier
23244720
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.
Results Reference
background
PubMed Identifier
19908092
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.
Results Reference
background
PubMed Identifier
30926185
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, 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.
Results Reference
background
PubMed Identifier
24475799
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.
Results Reference
background
PubMed Identifier
29921613
Citation
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.
Results Reference
background
PubMed Identifier
29894572
Citation
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.
Results Reference
background
Links:
URL
https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts
Description
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

Learn more about this trial

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

We'll reach out to this number within 24 hrs