NCT05531240

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

May 30, 2022

Last Update Submit

September 30, 2022

Conditions

Transurethral Resection of Prostate SyndromeProstate HyperplasiaEmbolization, Therapeutic

Keywords

Prostate embolisationPAE

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

EXPERIMENTAL

Prostate Artery Embolization (PAE)

Procedure: Prostate Artery Embolization

TURP

ACTIVE COMPARATOR

Transurethral Prostate Resection (TURP)

Procedure: Transurethral Prostate Resection (TURP)

Interventions

Prostate Artery EmbolizationPROCEDURE

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.

PAE
Transurethral Prostate Resection (TURP)PROCEDURE

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.

TURP

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prostate cancer
  • Severe atherosclerosis
  • Kidney failure
  • Urethral stricture
  • Active cystitis or prostatitis
  • Bladder stone.
  • Neurogenic bladder disorder
  • Contrast product allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsingborgs Hospital

Helsingborg, Region Skånes, 252 23, Sweden

NOT YET RECRUITING

Mälarsjukhuset

Eskilstuna, Region Sörmland, 633 49, Sweden

NOT YET RECRUITING

Lasarettet i Enköping

Enköping, Region Uppsala, 745 38, Sweden

NOT YET RECRUITING

Region Vastmanland Hospital

Västerås, Västmanland County, 721 89, Sweden

RECRUITING

Related Publications (11)

  • 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: 1714529BACKGROUND

  • 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.

    PMID: 7539561BACKGROUND

  • 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.

    PMID: 1279218BACKGROUND

  • 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.

    PMID: 32027007BACKGROUND

  • 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.

    PMID: 16458735BACKGROUND

  • 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.

    PMID: 23244720BACKGROUND

  • 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.

    PMID: 19908092BACKGROUND

  • 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.

    PMID: 30926185BACKGROUND

  • 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.

    PMID: 24475799BACKGROUND

  • 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.

    PMID: 29921613BACKGROUND

  • 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.

    PMID: 29894572BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Abbas Chabok

    CKF Västerås Uppsala university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emir Majbar, MD

CONTACT

+4621173000emir.majbar@regionvastmanland.se

Farhood Alamdari, MD, PhD

CONTACT

+4621173000farhood.alamdari@regionvastmanland.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

September 7, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2025

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR

Locations

SE(4)