NCT04084938 Artery Embolization vs Operation of Benign Prostate Hyperplasia
| NCT ID | NCT04084938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2019-09-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Nils Einar Kløw, MD, PHD
PRINCIPAL INVESTIGATOR
Department of Radiology, Oslo University Hospital
Frequently Asked Questions
Who can join the NCT04084938 clinical trial?
This trial is open to male participants only, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04084938 currently recruiting?
Yes, NCT04084938 is actively recruiting participants. Contact the research team at thihag@ous-hf.no for enrollment information.
Where is the NCT04084938 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT04084938 clinical trial?
NCT04084938 is sponsored by Oslo University Hospital. The principal investigator is Nils Einar Kløw, MD, PHD at Department of Radiology, Oslo University Hospital. The trial plans to enroll 140 participants.