Artery Embolization vs Operation of Benign Prostate Hyperplasia

Launched by OSLO UNIVERSITY HOSPITAL · Sep 7, 2019

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments for men with Benign Prostatic Hyperplasia (BPH), which causes uncomfortable urinary symptoms. The study will look at prostate artery embolization (PAE), a less invasive procedure, against traditional surgery to see which one is better in terms of how patients feel about the treatment, any complications, and recovery time. To participate, men need to have moderate to severe urinary symptoms that haven’t improved with medication for at least six months, and their prostate must be larger than 50 ml. Participants will be randomly assigned to either the embolization or surgery group.

If you join the trial, you will first have tests like a CT scan and MRI to ensure you qualify. If selected, you will receive either PAE, where tiny particles are injected into the arteries supplying the prostate, or surgery to remove prostate tissue. Participants will have follow-up visits at 3 months, 1 year, and 5 years to monitor their recovery and any complications. This study is currently recruiting participants, and it’s important to know that certain medical conditions may exclude you from participating, such as having prostate cancer or previous prostate surgery.

Gender

MALE

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.