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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostatic Artery Embolization (PAE) | Procedure | Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks after treatment initiation |
| International Prostate Symptoms Score (IPSS) |
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Inclusion Criteria:
Exclusion Criteria:
based on presence of a prostate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominik ABT, MD | Contact | 41714941418 | dominik.abt@kssg.ch |
| Name | Affiliation | Role |
|---|---|---|
| Dominik Abt, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
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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.
At the end of the study. Availability for at least 10 years.
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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1:1 randomized controlled study
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| Pharmacotherapy | Drug | Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations |
|
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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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) | laboratory test | 6 months after treatment initiation |
| Prostate specific antigen (PSA) | laboratory test | 1 year after treatment initiation |
| Prostate specific antigen (PSA) | laboratory test | 2 years after treatment initiation |
| Prostate specific antigen (PSA) | laboratory test | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 5 years after treatment initiation |
| D052801 |
| Male Urogenital Diseases |