Comparing prostate artery embolization to surgery for enlarged prostate treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare prostate artery embolization (PAE) with traditional surgical treatment for benign prostatic hyperplasia (BPH) in terms of patient acceptance, complications, and functional outcomes. A total of 140 patients suffering from lower urinary tract symptoms (LUTS) will be randomized to receive either PAE or surgery. Prior to randomization, patients will undergo imaging to ensure eligibility, and both procedures will be performed in specialized departments. Follow-up assessments will be conducted at 3 months, 1 year, and 5 years to evaluate recovery and complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Oslo University Hospital, Aker
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Nils Einar Kløw, MD, PHD — Department of Radiology, Oslo University Hospital
• Study coordinator: Thijs Hagen, MD
• Email: thihag@ous-hf.no
• Phone: + 47 45002349

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.