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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
425
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
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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