Status:
COMPLETED
Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Lead Sponsor:
Saskatchewan Health Authority - Regina Area
Conditions:
Benign Prostate Hyperplasia
Eligibility:
MALE
Phase:
PHASE2
PHASE3
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 treat...
Eligibility Criteria
Inclusion
- 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)
- Urinary retention (related to BPH) leading to catheterization.
- Refractory to medical treatment or patient is not willing to consider medical treatment
- Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.
Exclusion
- Mild symptoms (IPSS \<8)
- 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).
- Suspected malignancy.
- Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.
- Advanced atherosclerosis and unsuitable vascular access.
- Allergy to intravenous contra
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01835860
Start Date
March 1 2013
End Date
December 1 2015
Last Update
April 7 2016
Active Locations (1)
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1
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5