NCT03527589

Brief Summary

Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
4 countries

15 active sites

Status
completed

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

April 24, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

April 24, 2018

Results QC Date

May 5, 2022

Last Update Submit

December 12, 2023

Conditions

Benign Prostatic HyperplasiaLower Urinary Tract Symptoms

Keywords

Prostatic Artery Embolization (PAE)Benign Prostatic Hyperplasia (BPH)Lower Urinary Tract Symptoms (LUTS)EmbolizationEmbolicEmbosphere Microsphere

Outcome Measures

Primary Outcomes (1)

  • Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).

    The two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores on a scale' is the unite of measure

    12 Months

Secondary Outcomes (7)

  • International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.

    3, 24 Months

  • Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.

    3, 24 Months

  • Device or Procedure Related Adverse Events Post Procedure.

    3, 12, 24 Months

  • Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.

    3, 12, 24 Months

  • Technical Success Defined as Successful Embolization of the Treated Prostate Gland.

    Day of PAE Procedure

  • +2 more secondary outcomes

Study Arms (1)

Treated with Embosphere Microspheres

Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).

Device: Prostate artery embolization

Interventions

Prostate artery embolizationDEVICE

Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.

Treated with Embosphere Microspheres

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males can receive prostatic artery embolization
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with lower urinary tract sypmtoms (LUTS) due to benign prostatic hyperplasia (BPH)

You may qualify if:

  • Patient has signed informed consent
  • Patient age is 18 years or older at time of informed consent
  • Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms

You may not qualify if:

  • Patient is unable or unwilling to provide follow-up information
  • Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

VA Long Beach Healthcare Systems

Long Beach, California, 90822, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

UC Irvine Health

Orange, California, 92868, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

University of Miami- Miller School of Medicine

Miami, Florida, 33136, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Providence Sacred Heart

Spokane, Washington, 99204, United States

Location

Hôspital Européan Georges Pompidou HEGP

Paris, 75015, France

Location

Azienda Ospedaliera S. Croce e Carle Cuneo

Cuneo, 12100, Italy

Location

Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

Location

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

Frimley Park Hospital

Camberley, Surrey, GU16 7UJ, United Kingdom

Location

Royal Bournemouth and Christchurch Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

Related Publications (1)

  • Sapoval MR, Bhatia S, Dean C, Rampoldi A, Carnevale FC, Bent C, Tapping CR, Bongiovanni S, Taylor J, Brower JS, Rush M, McWilliams JP, Little MW; PROstate Study Investigators. Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study. Cardiovasc Intervent Radiol. 2024 Nov;47(11):1515-1524. doi: 10.1007/s00270-024-03802-0. Epub 2024 Sep 4.

    PMID: 39230672DERIVED

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Casey Holland
Organization
Merit Medical
casey.holland@merit.com
6178420251

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 17, 2018

Study Start

August 16, 2018

Primary Completion

January 21, 2020

Study Completion

January 22, 2022

Last Updated

December 18, 2023

Results First Posted

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(8)GB(4)IT(2)FR(1)