Benign Prostate Hyperplasia
Conditions
Keywords
BPH
Brief summary
To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).
Interventions
PROCEDUREProstate artery embolization
Sponsors
Saskatchewan Health Authority - Regina Area
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
1. Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS\>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living) 2. Urinary retention (related to BPH) leading to catheterization. 3. Refractory to medical treatment or patient is not willing to consider medical treatment 4. Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.
Exclusion criteria
1. Mild symptoms (IPSS \<8) 2. Moderate to severe lower urinary tract symptoms (i.e. IPSS\>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living). 3. Suspected malignancy. 4. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency. 5. Advanced atherosclerosis and unsuitable vascular access. 6. Allergy to intravenous contra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS). | 1, 3, 6 and 12 months |
Countries
Canada
Outcome results
None listed