Status:
RECRUITING
Artery Embolization vs Operation of Benign Prostate Hyperplasia
Lead Sponsor:
Oslo University Hospital
Conditions:
Benign Prostatic Hyperplasia
Post-Op Complication
Eligibility:
MALE
Phase:
NA
Brief Summary
Aim of the study is to compare prostate artery embolization (PAE) to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length...
Detailed Description
Background: Prostatic artery embolization (PAE) has recently been described as a promising alternative to surgery for treatment of lower urinary tract symptoms (LUTS) due to an enlarged, benign prosta...
Eligibility Criteria
Inclusion
- LUTS from Benign Prostate Hyperplasia (BPH) with moderate and severe IPSS score (IPSS \> 8) and QoL = or \>3
- and refractory to medical treatment for at least 6 months or the patient is unwilling to accept medical treatment
- or BPH using permanent or intermittent catheterization
- Prostate volume \> 50 ml
- Signed informed consent
Exclusion
- Urological disorders: evidence of clinically significant prostate cancer \[as defined by START criteria\] on prostate biopsy (27,28), prostatitis (29,30), detrusor-sphincter dyssynergia or evidence of neurogenic bladder, urethral strictures, bladder neck contracture, bladder stone or bladder cancer
- Renal insufficiency defined as Glomerular Filtration Rate \< 30 ml/min/1,73m2
- Known severe reactions to iodine-based contrast or gadolinium-based contrast
- Previous prostate operation
- CT examination reveals no access to the prostate arteries.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04084938
Start Date
September 1 2019
End Date
December 31 2027
Last Update
December 27 2023
Active Locations (1)
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1
Oslo University Hospital, Aker
Oslo, Norway