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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holmium laser enucleation of the prostate | Experimental | Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra |
|
| Artery embolization of the prostate | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium laser enucleation of the prostate | Device | Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of symptoms assessed by International Prostate Symptom Score (IPSS) | 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) | Baseline to 6 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum urinary flow | Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s). | Baseline to 6 months after procedure |
| Post-void residual urinary volume | Post-void residual urinary volume (PVR). Post-void urinary volume: evaluated in milliliters (mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Agreda, MD | Contact | +34934893000 | fagreda.germanstrias@gencat.cat | |
| Jaume Sampere, MD | Contact | +34934893000 | jsampere.germanstrias@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Agreda, MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
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| Artery embolization of the prostate | Procedure | 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 |
|
| Baseline to 6 months after procedure |
| Prostate specific antigen (PSA) | Determination in plasma of the prostate specific antigen (PSA) | Baseline to 6 months after procedure |
| Procedure related adverse events | 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) | Baseline to 6 months after procedure |
| Procedure related effects on sexual function | 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). | Baseline to 6 months after procedure |
| Procedure related effects on urinary continence | 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) | Baseline to 6 months after procedure |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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