Artery Embolization vs Operation of Benign Prostate Hyperplasia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    140
  • sponsor
    Oslo University Hospital
Updated on 27 January 2021
cancer
lower urinary tract symptoms
artery embolization
prostate surgery
hyperplasia

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 of stay, hospital costs and time for recovery. 140 patients will be randomized to PAE or surgery. Patients should suffer from lower urinary tract symptoms (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 injecting small particles into the prostate arteries. The surgery is done in the operation room in the urology department according to established procedures. Clinical follow-up include clinical visit after 3 months, 1 and 5 years. Acute as well as long term complications will be recorded.

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 prostate. The treatment has not been implemented into international guidelines and has only been introduced to few patients in Norway.

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.

Details
Condition Benign prostatic hypertrophy, Postoperative Complication, Prostatic disorder, Embolization, Prostate Disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), Transurethral Resection of Prostate Syndrome, benign prostatic hyperplasia
Treatment Prostate operation or prostate artery embolization
Clinical Study IdentifierNCT04084938
SponsorOslo University Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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