A Phase 3 interventional study of Prostatic Artery Embolization (PAE) and Pharmacotherapy in Benign Prostatic Hyperplasia, Pharmacotherapy and Prostatic Artery Embolization, sponsored by Dominik Abt. Not yet recruiting. Open to male participants aged 45 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Dominik Abt · Phase 3, Interventional, and Treatment
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 425 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Dominik Abt is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations
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.
Time frame: 24 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 5 years after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Time frame: 6 months after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Time frame: 1 year after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Time frame: 2 years after treatment initiation
Prostate specific antigen (PSA)
laboratory test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 5 years after treatment initiation
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: At the end of the study. Availability for at least 10 years.
No publications or documents are linked to this record.
Start is estimated for Sep 2021; primary completion for Dec 2022, 15 months later.
Of 17 phase 3 interventional studies under Prostatic Hyperplasia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 50. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dominik Abt