Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)
Study Overview
Brief Summary
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostate artery embolization (PAE) with microspheres (Embozene™, 400µm) compared to conventional Holmium laser enucleation of the prostate (HoLEP).
Detailed Description
This is a prospective randomized controlled study that collects data of patients with benign prostatic hyperplasia that are treated with prostatic artery embolization (PAE) or with Holmium laser enucleation of the prostate (HoLEP). For PAE a catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. For HoLEP a Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra. Clinical follow-up include clinical visit after 1, 6 and 12 months. Acute as well as long term complications will be recorded. The patients fill in the questionnaires for urologic disease. Urodynamic examination will record functional outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients evaluated in the urology department and candidates to surgical treatment
- •Age > 45 years
- •IPSS ≥ 10
- •Maximum urinary flow < 12 milliliters (mL)/second (s)
- •Post-void residual urinary volume < 300mL
- •Prostatic volume between 20mL and 250mL assessed by ultrasound
- •Signed informed consent
Exclusion Criteria
- •PSA > 10 (if not negative prostate biopsy)
- •Life expectancy below 1 year
- •Renal insufficiency defined as Glomerular Filtration Rate < 30 ml/min/1,73m2
- •Known severe reactions to iodine-based contrast or gadolinium-based contrast
- •CT examination reveals no access to the prostate arteries.
Outcomes
Primary Outcomes
Improvement of symptoms assessed by International Prostate Symptom Score (IPSS)
Time Frame: Baseline to 6 months after procedure
Change in prostatic symptoms using the International Prostate Symptom Score (IPSS). IPSS score goes from 0 to 35. Higher values mean worse outcome (prostate symptons)
Secondary Outcomes
- Maximum urinary flow(Baseline to 6 months after procedure)
- Post-void residual urinary volume(Baseline to 6 months after procedure)
- Prostate specific antigen (PSA)(Baseline to 6 months after procedure)
- Procedure related adverse events(Baseline to 6 months after procedure)
- Procedure related effects on sexual function(Baseline to 6 months after procedure)
- Procedure related effects on urinary continence(Baseline to 6 months after procedure)