Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Sweden
Lasarettet i Enköping
NOT_YET_RECRUITING
Enköping
Mälarsjukhuset
NOT_YET_RECRUITING
Eskilstuna
Helsingborgs Hospital
NOT_YET_RECRUITING
Helsingborg
Region Vastmanland Hospital
RECRUITING
Västerås
Contact Information
Primary
Emir Majbar, MD
emir.majbar@regionvastmanland.se
+4621173000
Backup
Farhood Alamdari, MD, PhD
farhood.alamdari@regionvastmanland.se
+4621173000
Time Frame
Start Date: 2022-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 104
Treatments
Experimental: PAE
Prostate Artery Embolization (PAE)
Active_comparator: TURP
Transurethral Prostate Resection (TURP)
Related Therapeutic Areas
Sponsors
Collaborators: Lasarettet i Enköping, Sormland County Council, Sweden, Centrallasarettet Västerås, Helsingborgs Hospital
Leads: Uppsala University