Benign Prostatic Hyperplasia
Conditions
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.
Interventions
Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
PROCEDUREArtery embolization of the prostate
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
Sponsors
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of symptoms assessed by International Prostate Symptom Score (IPSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-void residual urinary volume | Baseline to 6 months after procedure | Post-void residual urinary volume (PVR). Post-void urinary volume: evaluated in milliliters (mL) |
| Prostate specific antigen (PSA) | Baseline to 6 months after procedure | Determination in plasma of the prostate specific antigen (PSA) |
| Maximum urinary flow | Baseline to 6 months after procedure | Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s). |
| Procedure related effects on sexual function | Baseline to 6 months after procedure | Changes in sexual function assessed by International Index of Erectile Function (IIEF) score. IIEF: the score goes from 6 to 75. Lower values mean worse outcome (overall male sexual function). |
| Procedure related effects on urinary continence | Baseline to 6 months after procedure | Changes in urinary continence assessed by the International Consultation on Continence Questionnaire Short Form (ICIQ-SF). ICIQ-SF: score goes from 0 to 21. Higher values mean worse outcome (urinary continence) |
| Procedure related adverse events | Baseline to 6 months after procedure | Evaluation of Procedure related adverse events assessed by Clavien-Dindo modified score. Clavien Dindo modified score: the score goes from 1 to 5. Higher values mean worse outcome (surgical complications) |
Countries
Spain
Contacts
Primary ContactFernando Agreda, MD
Backup ContactJaume Sampere, MD
Outcome results
None listed