An interventional study of Holmium laser enucleation of the prostate and Artery embolization of the prostate in Benign Prostatic Hyperplasia, sponsored by Germans Trias i Pujol Hospital. Status unknown at 1 site in Spain. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Germans Trias i Pujol Hospital · Not applicable, Interventional, and Treatment
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 100 is close to the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Germans Trias i Pujol Hospital is the lead sponsor of 87 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
Device: Holmium laser enucleation 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. The injected microspheres will slow the blood flow to the prostate.
Procedure: Artery embolization of the prostate
Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
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
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)
Time frame: Baseline to 6 months after procedure
Maximum urinary flow
Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s).
Time frame: 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)
Time frame: Baseline to 6 months after procedure
Prostate specific antigen (PSA)
Determination in plasma of the prostate specific antigen (PSA)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: Baseline to 6 months after procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Germans Trias i Pujol Hospital