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Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236687
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Germans Trias i Pujol Hospital

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).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Holmium laser enucleation of the prostate Procedure: Artery embolization of the prostate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium

Arm Intervention/treatment
Experimental: Holmium laser enucleation of the prostate
Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
Device: Holmium laser enucleation of the prostate
Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra

Active Comparator: Artery 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. The injected microspheres will slow the blood flow to the prostate.
Procedure: Artery 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maximum urinary flow [ Time Frame: Baseline to 6 months after procedure ]
    Maximum urinary flow rate (Qmax). Evaluated in milliliter per seconds (mL/s).

  2. Post-void residual urinary volume [ Time Frame: Baseline to 6 months after procedure ]
    Post-void residual urinary volume (PVR). Post-void urinary volume: evaluated in milliliters (mL)

  3. Prostate specific antigen (PSA) [ Time Frame: Baseline to 6 months after procedure ]
    Determination in plasma of the prostate specific antigen (PSA)

  4. Procedure related adverse events [ Time Frame: 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)

  5. Procedure related effects on sexual function [ Time Frame: 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).

  6. Procedure related effects on urinary continence [ Time Frame: 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)



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236687


Contacts
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Contact: Fernando Agreda, MD +34934893000 fagreda.germanstrias@gencat.cat
Contact: Jaume Sampere, MD +34934893000 jsampere.germanstrias@gencat.cat

Locations
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Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Contact: Fernando Agreda, MD    +34934893000    fagreda.germanstrias@gencat.cat   
Contact: Jaume Sanpere, MD    +34934893000    fagreda.germanstrias@gencat.cat   
Principal Investigator: Fernando Agreda, MD         
Sub-Investigator: Jaume Sanpere, MD         
Sub-Investigator: Gerardo Tovar, MD         
Sub-Investigator: Daniel Salvador, MD         
Sub-Investigator: Mauro Bernardello, MD         
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Fernando Agreda, MD Germans Trias i Pujol Hospital

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Responsible Party: Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT04236687    
Other Study ID Numbers: HBP01
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male