Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH (EMPATHY)

January 25, 2021 updated by: Dominik Abt

Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial

This study compares safety and efficacy of prostatic artery embolization and pharmacotherapy in the treatment of lower urinary tract symptoms associated wit benign prostatic hyperplasia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
425

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • men ≥45 years of age
  • lower urinary tract symptoms assigned to BPH (diagnosis by medical history and physical examination)
  • IPSS ≥ 8 points
  • QoL ≥ 3 points
  • Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml
  • informed consent for study participation

Exclusion Criteria:

  • renal impairment (GFR < 30ml/min)
  • previous prostatic surgery
  • 5-alpha reductase inhibitor (5-ARI) use within 6 mo (or dutasteride within 12 mo) prior to entry, or use of an α-blocker or phytotherapy for BPH within 2 weeks prior to entry
  • history or evidence of prostate cancer
  • absolute indication for surgical treatment of complications related to BPH (i.e. bladder stones, renal impairment due to bladder outlet obstruction)
  • history of neurogenic bladder dysfunction
  • not able to complete questionnaires due to cognitive or thought disorders
  • language skills insufficient for informed consent and / or completion of questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Prostatic Artery Embolization (PAE)
PAE will be performed as an inpatient or outpatient procedure by interventional radiologists who are familiar with the procedure and according to established techniques. A unilateral femoral sheath is placed in the right common femoral artery under local anaesthesia. The prostatic arterial supply is identified by selective internal iliac arteriography. Prostatic arteries are selectively catheterised and embolised by use of 250-600 μm microspheres . PAE is performed bilaterally if possible and considered successful in the absence of the normal blush of the prostate and stasis of flow in the prostate arteries on angiography after embolisation.
Procedure: Prostatic Artery Embolization (PAE)
Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
PLACEBO_COMPARATOR: Pharmocotherapy
Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations. Thus, patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin plus 0.5 mg dutasteride once daily during the complete study follow-up.
Drug: Pharmacotherapy
Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
International Prostate Symptoms Score (IPSS)
Time Frame: 24 months after treatment initiation
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
24 months after treatment initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
International Prostate Symptoms Score (IPSS)
Time Frame: 6 weeks after treatment initiation
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
6 weeks after treatment initiation
International Prostate Symptoms Score (IPSS)
Time Frame: 6 months after treatment initiation
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
6 months after treatment initiation
International Prostate Symptoms Score (IPSS)
Time Frame: 1 year after treatment initiation
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
1 year after treatment initiation
International Prostate Symptoms Score (IPSS)
Time Frame: 5 year after treatment initiation
The International Prostate Symptoms Score (IPSS) measures the degree of symptoms associated with benign prostatic hyperplasia (BPH). Range of values 0-35 points. Higher values indicate more severe symptoms.
5 year after treatment initiation
Self-assessed goal achievement (SAGA)
Time Frame: 6 weeks after treatment initiation
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
6 weeks after treatment initiation
Self-assessed goal achievement (SAGA)
Time Frame: 6 months after treatment initiation
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment SAGA is a PROM focusing on individual treatment goals
6 months after treatment initiation
Self-assessed goal achievement (SAGA)
Time Frame: 1 year after treatment initiation
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
1 year after treatment initiation
Self-assessed goal achievement (SAGA)
Time Frame: 2 years after treatment initiation
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
2 years after treatment initiation
Self-assessed goal achievement (SAGA)
Time Frame: 5 years after treatment initiation
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
5 years after treatment initiation
Maximum urinary stream (Qmax)
Time Frame: 6 weeks after treatment initiation
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
6 weeks after treatment initiation
Maximum urinary stream (Qmax)
Time Frame: 6 months after treatment initiation
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
6 months after treatment initiation
Maximum urinary stream (Qmax)
Time Frame: 1 year after treatment initiation
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
1 year after treatment initiation
Maximum urinary stream (Qmax)
Time Frame: 2 years after treatment initiation
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
2 years after treatment initiation
Maximum urinary stream (Qmax)
Time Frame: 5 years after treatment initiation
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
5 years after treatment initiation
Post void residual urine (PVR)
Time Frame: 6 weeks after treatment initiation
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
6 weeks after treatment initiation
Post void residual urine (PVR)
Time Frame: 6 months after treatment initiation
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
6 months after treatment initiation
Post void residual urine (PVR)
Time Frame: 1 year after treatment initiation
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
1 year after treatment initiation
Post void residual urine (PVR)
Time Frame: 2 years after treatment initiation
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
2 years after treatment initiation
Post void residual urine (PVR)
Time Frame: 5 years after treatment initiation
Post void residual is measured after voiding by transabdominal ultrasound and calculated in mL. Higher values indicate more post void residual urine and a worse ability to empty the bladder.
5 years after treatment initiation
Prostate volume
Time Frame: 6 moths after treatment initiation
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
6 moths after treatment initiation
Prostate volume
Time Frame: 2 years after treatment initiation
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
2 years after treatment initiation
Prostate volume
Time Frame: 5 years after treatment initiation
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
5 years after treatment initiation
Prostate specific antigen (PSA)
Time Frame: 6 months after treatment initiation
laboratory test
6 months after treatment initiation
Prostate specific antigen (PSA)
Time Frame: 1 year after treatment initiation
laboratory test
1 year after treatment initiation
Prostate specific antigen (PSA)
Time Frame: 2 years after treatment initiation
laboratory test
2 years after treatment initiation
Prostate specific antigen (PSA)
Time Frame: 5 years after treatment initiation
laboratory test
5 years after treatment initiation
Safety / adverse events
Time Frame: 6 weeks after treatment initiation
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
6 weeks after treatment initiation
Safety / adverse events
Time Frame: 6 months after treatment initiation
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
6 months after treatment initiation
Safety / adverse events
Time Frame: 1 year after treatment initiation
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
1 year after treatment initiation
Safety / adverse events
Time Frame: 2 year after treatment initiation
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
2 year after treatment initiation
Safety / adverse events
Time Frame: 5 year after treatment initiation
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
5 year after treatment initiation
Erectile function
Time Frame: 6 weeks after treatment initiation
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
6 weeks after treatment initiation
Erectile function
Time Frame: 6 months after treatment initiation
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
6 months after treatment initiation
Erectile function
Time Frame: 1 year after treatment initiation
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
1 year after treatment initiation
Erectile function
Time Frame: 2 year after treatment initiation
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
2 year after treatment initiation
Erectile function
Time Frame: 5 year after treatment initiation
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
5 year after treatment initiation
Ejaculatory function
Time Frame: 6 weeks after treatment initiation
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
6 weeks after treatment initiation
Ejaculatory function
Time Frame: 6 months after treatment initiation
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
6 months after treatment initiation
Ejaculatory function
Time Frame: 1 year after treatment initiation
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
1 year after treatment initiation
Ejaculatory function
Time Frame: 2 years after treatment initiation
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
2 years after treatment initiation
Ejaculatory function
Time Frame: 5 years after treatment initiation
Assessed by the questionnaire Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD). Ejaculatory function total score (questions 1-3, possible range 0-15, higher values indicate better ejaculatory function, and MSHQ-EjD ejaculatory bother item (question 4, possible range 0-5, higher values indicate more bother).
5 years after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
Time Frame: 6 weeks after treatment initiation
assessed by patient interviews at follow up visit
6 weeks after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
Time Frame: 6 moths after treatment initiation
assessed by patient interviews at follow up visit
6 moths after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
Time Frame: 1 year after treatment initiation
assessed by patient interviews at follow up visit
1 year after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
Time Frame: 2 years after treatment initiation
assessed by patient interviews at follow up visit
2 years after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
Time Frame: 5 years after treatment initiation
assessed by patient interviews at follow up visit
5 years after treatment initiation
Analysis of cost-effectiveness using quality-adjusted life years (QALY)
Time Frame: 2 years after treatment initiation
One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). To estimate QALY costs will be calculated by calculation of treatment costs, and quality of life will be assessed using the questionnaire EQ-5D. EQ-5D measures five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents self-rate their level of severity for each dimension using a five-level scale. The questionnaire can define 3,125 different health states.
2 years after treatment initiation
Analysis of cost-effectiveness using quality-adjusted life years (QALY)
Time Frame: 5 years after treatment initiation
One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). To estimate QALY costs will be calculated by calculation of treatment costs, and quality of life will be assessed using the questionnaire EQ-5D. EQ-5D measures five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents self-rate their level of severity for each dimension using a five-level scale. The questionnaire can define 3,125 different health states.
5 years after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dominik Abt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTU19/025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the end of the study, data are stored in a publicly accessible repository (e.g.

Harvard Dataverse or Zenodo, depending on whether the data should be stored on a server in America or Europe). All elements are stored with a unique Digital Object Identifier (DOI), which can be referenced in the respective publication.

IPD Sharing Time Frame

At the end of the study. Availability for at least 10 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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