Benign Prostatic HyperplasiaPhase 3EMPATHYNCT04245566
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
A Phase 3 study testing Prostatic Artery Embolization (PAE) and Pharmacotherapy in people with Benign Prostatic Hyperplasia and Pharmacotherapy, run by Dominik Abt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 100 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Pharmacotherapy, Prostatic Artery Embolization
- What is being tested?
- Prostatic Artery Embolization (PAE) and Pharmacotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Benign Prostatic Hyperplasia, Pharmacotherapy, Prostatic Artery Embolization, Minimally Invasive Treatment
- Being tested
- Prostatic Artery Embolization (PAE), Pharmacotherapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery Embolization (PAE)Procedure or surgery
Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
PharmacotherapyDrug
Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | 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. Receives: Procedure: Prostatic Artery Embolization (PAE) |
| Pharmocotherapy | Placebo comparator | 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. Receives: Drug: Pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptoms Score (IPSS)
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.
Measured: 24 months after treatment initiation
Secondary outcomes (48)
International Prostate Symptoms Score (IPSS)
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.
Measured: 6 weeks after treatment initiation
International Prostate Symptoms Score (IPSS)
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.
Measured: 6 months after treatment initiation
International Prostate Symptoms Score (IPSS)
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.
Measured: 1 year after treatment initiation
International Prostate Symptoms Score (IPSS)
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.
Measured: 5 year after treatment initiation
Self-assessed goal achievement (SAGA)
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Measured: 6 weeks after treatment initiation
Self-assessed goal achievement (SAGA)
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
Measured: 6 months after treatment initiation
Self-assessed goal achievement (SAGA)
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Measured: 1 year after treatment initiation
Self-assessed goal achievement (SAGA)
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Measured: 2 years after treatment initiation
Self-assessed goal achievement (SAGA)
SAGA is a PROM focusing on individual treatment goals SAGA is a patient reported outcome measure focusing on individual treatment goals
Measured: 5 years after treatment initiation
Maximum urinary stream (Qmax)
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Measured: 6 weeks after treatment initiation
Maximum urinary stream (Qmax)
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Measured: 6 months after treatment initiation
Maximum urinary stream (Qmax)
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Measured: 1 year after treatment initiation
Maximum urinary stream (Qmax)
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Measured: 2 years after treatment initiation
Maximum urinary stream (Qmax)
Urinary stream will be measured by free uroflowmetry and recorded in mL per second. Higher values indicate a better maximum urinary stream.
Measured: 5 years after treatment initiation
Post void residual urine (PVR)
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.
Measured: 6 weeks after treatment initiation
Post void residual urine (PVR)
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.
Measured: 6 months after treatment initiation
Post void residual urine (PVR)
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.
Measured: 1 year after treatment initiation
Post void residual urine (PVR)
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.
Measured: 2 years after treatment initiation
Post void residual urine (PVR)
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.
Measured: 5 years after treatment initiation
Prostate volume
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Measured: 6 moths after treatment initiation
Prostate volume
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Measured: 2 years after treatment initiation
Prostate volume
Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
Measured: 5 years after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Measured: 6 months after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Measured: 1 year after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Measured: 2 years after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Measured: 5 years after treatment initiation
Safety / adverse events
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Measured: 6 weeks after treatment initiation
Safety / adverse events
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Measured: 6 months after treatment initiation
Safety / adverse events
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Measured: 1 year after treatment initiation
Safety / adverse events
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Measured: 2 year after treatment initiation
Safety / adverse events
Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
Measured: 5 year after treatment initiation
Erectile function
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Measured: 6 weeks after treatment initiation
Erectile function
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Measured: 6 months after treatment initiation
Erectile function
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Measured: 1 year after treatment initiation
Erectile function
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Measured: 2 year after treatment initiation
Erectile function
Assessed by the questionnaire IIEF-5. Score of IIEF-5 can range from 0 to 25 points. Higher values indicate a better erectile function.
Measured: 5 year after treatment initiation
Ejaculatory function
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).
Measured: 6 weeks after treatment initiation
Ejaculatory function
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).
Measured: 6 months after treatment initiation
Ejaculatory function
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).
Measured: 1 year after treatment initiation
Ejaculatory function
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).
Measured: 2 years after treatment initiation
Ejaculatory function
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).
Measured: 5 years after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
assessed by patient interviews at follow up visit
Measured: 6 weeks after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
assessed by patient interviews at follow up visit
Measured: 6 moths after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
assessed by patient interviews at follow up visit
Measured: 1 year after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
assessed by patient interviews at follow up visit
Measured: 2 years after treatment initiation
Need for additional drug treatment, surgical treatment or change of medical treatment assessed
assessed by patient interviews at follow up visit
Measured: 5 years after treatment initiation
Analysis of cost-effectiveness using quality-adjusted life years (QALY)
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.
Measured: 2 years after treatment initiation
Analysis of cost-effectiveness using quality-adjusted life years (QALY)
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.
Measured: 5 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study startSep 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized controlled study
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominik Abt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominik Abt, Cantonal Hospital of St. Gallen
- Investigators
- Dominik Abt, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245566
- Sponsor's protocol ID
- CTU19/025
- Acronym
- EMPATHY
- Status last verified
- Jan 2021
- First submitted
- 23 Jan 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04245566
- Acronym / sponsor ID
- EMPATHY / CTU19/025
- Conditions
- Benign Prostatic Hyperplasia, Pharmacotherapy, Prostatic Artery Embolization, Minimally Invasive Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Dominik AbtUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Prostatic Artery Embolization (PAE) | Experimental | Procedure: 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. |
| Pharmocotherapy | Placebo comparator | Drug: PharmacotherapyPharmacotherapy 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. |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostatic Artery Embolization (PAE)Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques. | Procedure or surgery | Prostatic Artery Embolization (PAE) |
| PharmacotherapyPharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations | Drug | Pharmocotherapy |
Primary outcome
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.
48 secondary outcomes
International Prostate Symptoms Score (IPSS)
Time frame: 6 weeks after treatment initiation
International Prostate Symptoms Score (IPSS)
Time frame: 6 months after treatment initiation
International Prostate Symptoms Score (IPSS)
Time frame: 1 year after treatment initiation
International Prostate Symptoms Score (IPSS)
Time frame: 5 year after treatment initiation
Self-assessed goal achievement (SAGA)
Time frame: 6 weeks after treatment initiation
Self-assessed goal achievement (SAGA)
Time frame: 6 months after treatment initiation
Self-assessed goal achievement (SAGA)
Time frame: 1 year after treatment initiation
Self-assessed goal achievement (SAGA)
Time frame: 2 years after treatment initiation
Self-assessed goal achievement (SAGA)
Time frame: 5 years after treatment initiation
Maximum urinary stream (Qmax)
Time frame: 6 weeks after treatment initiation
Maximum urinary stream (Qmax)
Time frame: 6 months after treatment initiation
Maximum urinary stream (Qmax)
Time frame: 1 year after treatment initiation
Maximum urinary stream (Qmax)
Time frame: 2 years after treatment initiation
Maximum urinary stream (Qmax)
Time frame: 5 years after treatment initiation
Post void residual urine (PVR)
Time frame: 6 weeks after treatment initiation
Post void residual urine (PVR)
Time frame: 6 months after treatment initiation
Post void residual urine (PVR)
Time frame: 1 year after treatment initiation
Post void residual urine (PVR)
Time frame: 2 years after treatment initiation
Post void residual urine (PVR)
Time frame: 5 years after treatment initiation
Prostate volume
Time frame: 6 moths after treatment initiation
Prostate volume
Time frame: 2 years after treatment initiation
Prostate volume
Time frame: 5 years after treatment initiation
Prostate specific antigen (PSA)
Time frame: 6 months after treatment initiation
Prostate specific antigen (PSA)
Time frame: 1 year after treatment initiation
Prostate specific antigen (PSA)
Time frame: 2 years after treatment initiation
Prostate specific antigen (PSA)
Time frame: 5 years after treatment initiation
Safety / adverse events
Time frame: 6 weeks after treatment initiation
Safety / adverse events
Time frame: 6 months after treatment initiation
Safety / adverse events
Time frame: 1 year after treatment initiation
Safety / adverse events
Time frame: 2 year after treatment initiation
Safety / adverse events
Time frame: 5 year after treatment initiation
Erectile function
Time frame: 6 weeks after treatment initiation
Erectile function
Time frame: 6 months after treatment initiation
Erectile function
Time frame: 1 year after treatment initiation
Erectile function
Time frame: 2 year after treatment initiation
Erectile function
Time frame: 5 year after treatment initiation
Ejaculatory function
Time frame: 6 weeks after treatment initiation
Ejaculatory function
Time frame: 6 months after treatment initiation
Ejaculatory function
Time frame: 1 year after treatment initiation
Ejaculatory function
Time frame: 2 years after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Abt, MD principal investigator
Cantonal Hospital of St. Gallen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prostatic Artery Embolization (PAE) and Pharmacotherapy in people with Benign Prostatic Hyperplasia and Pharmacotherapy, run by Dominik Abt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominik ABT, MD (41714941418, dominik.abt@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptoms Score (IPSS) (time frame: 24 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.