Embolization, Therapeutic, Prostate Hyperplasia, Transurethral Resection of Prostate Syndrome
Conditions
Keywords
Prostate embolisation, PAE
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.
Interventions
PROCEDUREProstate Artery Embolization
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.
PROCEDURETransurethral Prostate Resection (TURP)
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.
Sponsors
Centrallasarettet Västerås
Lasarettet i Enköping
Sormland County Council, Sweden
Helsingborgs Hospital
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of lower urinary tract symptoms | 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 | 24 months | Assess the health care costs after prostate artery embolization procedure (PAE) compared to transurethral resection of the prostate (TURP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects, | 24 months | 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 ]) | 24 months | 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 | 24 months | 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) | 24 months | Assess the change in PSA |
Countries
Sweden
Contacts
Primary ContactEmir Majbar, MD
Backup ContactFarhood Alamdari, MD, PhD
Outcome results
None listed