Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 104
- Locations
- 8
- Primary Endpoint
- Improvement of lower urinary tract symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
- •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
Outcomes
Primary Outcomes
Improvement of lower urinary tract symptoms
Time Frame: 24 months
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
Time Frame: 24 months
Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP)
Secondary Outcomes
- Quality of life (Short Form Health Survey [EQ-5D-5L ])(24 months)
- Prostate-Specific Antigen (PSA)(24 months)
- Erectile function(24 months)
- Adverse effects,(24 months)