Comparing prostate artery embolization to surgery for enlarged prostate treatment
Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia
NA · Oslo University Hospital · NCT04084938
This study is testing whether a new procedure called prostate artery embolization works as well as traditional surgery for men with an enlarged prostate and bothersome urinary symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Sex | Male |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04084938 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with moderate to severe LUTS due to BPH, refractory to medical treatment, and willing to undergo both PAE and surgery.
Not a fit: Patients with clinically significant prostate cancer, severe renal insufficiency, or previous prostate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with benign prostatic hyperplasia, potentially reducing recovery time and complications.
How similar studies have performed: While PAE has shown promise in preliminary studies, it has not yet been widely adopted into clinical guidelines, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia, Post-Op Complication, Embolization Therapeutic, Transurethral Resection of Prostate Syndrome, Prostate, Embolization, Complication, Operation