Prostatic Artery Embolization vs Transurethral Resection of the Prostate or Open Prostatectomy in Patients With Symptomatic Benign Prostatic Hyperplasia

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Oslo University Hospital, Aker
RECRUITING
Oslo
Contact Information
Primary
Thijs Hagen, MD
thihag@ous-hf.no
+ 47 45002349
Backup
Eduard Baco, MD, PHD
eduaba@online.no
+47 95221378
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 140
Treatments
Active_comparator: Prostate operation
You will have a surgery to remove the prostate gland. The surgery will be done during general anesthesia. If your prostate gland is small the surgery will be done through a catheter into the penis. If your prostate gland is large the surgery will be through an incision in your lower abdomen.
Active_comparator: Prostate artery embolization
The embolization is done in the Department of Radiology. There will be placement of a catheter into the artery in one of the groins during local anesthesia. Through this catheter small particles will be injected into the arteries of the prostate gland. When finished, the hole in the artery will be closed.
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov