Artery Embolization vs Operation of Benign Prostate Hyperplasia
NCT ID: NCT04084938
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2019-09-01
2027-12-31
Brief Summary
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Detailed Description
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Purpose: To compare PAE to the established surgical treatment for patient acceptance, morbidity, complications, and the functional outcomes. To compare length of stay, hospital costs and time for recovery.
Materials and Methods: 140 patients will be randomized to PAE or surgery. Patients should suffer from LUTS, be candidates for both treatments and willing to undergo both procedures. Before randomization computed tomography angiography of the pelvic arteries is done to select eligible patients. Magnetic resonance imaging of prostate rules out possible cancer. The PAE is done in the angio suite in the radiology department injection small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. All patients stay in the urology unit after the procedure. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded. The patients fill in the form of quality of life from urologic disease. Urodynamic examination will record functional outcome. Length of stay, procedure costs and recovery time will be recorded.
Importance of the study: Contribute to establishment of new treatment and help to select the right patients for the alternative treatments. Randomized study will give important information to the international community. It is possible to run this study in Norway because it is still in limited use.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prostate operation
You will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. If your prostate gland is small the surgery will be done through a catheter into the penis. If your prostate gland is large the surgery will be through an incision in your lower abdomen.
Prostate operation or prostate artery embolization
As described above.
Prostate artery embolization
The embolization is done in the Department of Radiology. There will be placement of a catheter into the artery in one of the groins during local anesthesia. Through this catheter small particles will be injected into the arteries of the prostate gland. When finished, the hole in the artery will be closed.
Prostate operation or prostate artery embolization
As described above.
Interventions
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Prostate operation or prostate artery embolization
As described above.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
MALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Nils-Einar Kløw
Professor
Principal Investigators
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Nils Einar Kløw, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiology, Oslo University Hospital
Locations
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Oslo University Hospital, Aker
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Thijs Hagen, MD
Role: primary
Eduard Baco, MD, PHD
Role: backup
Other Identifiers
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2018/1231
Identifier Type: -
Identifier Source: org_study_id