NCT04236687

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 15, 2020

Last Update Submit

January 21, 2020

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Holmium laser enucleation of the prostate

EXPERIMENTAL

Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra

Device: Holmium laser enucleation of the prostate

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.

Procedure: Artery embolization of the prostate

Interventions

Holmium laser enucleation of the prostateDEVICE

Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra

Holmium laser enucleation of the prostate
Artery embolization of the prostatePROCEDURE

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

Artery embolization of the prostate

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fernando Agreda, MD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Agreda, MD

CONTACT

+34934893000fagreda.germanstrias@gencat.cat

Jaume Sampere, MD

CONTACT

+34934893000jsampere.germanstrias@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 22, 2020

Study Start

February 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

ES(1)