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

Primary Purpose

Benign Prostatic Hyperplasia, Pharmacotherapy, Prostatic Artery Embolization

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Prostatic Artery Embolization (PAE)
Pharmacotherapy
Sponsored by
Dominik Abt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Prostatic Artery Embolization (PAE)

    Pharmocotherapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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
    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
    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
    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
    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
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Prostate volume
    Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
    Prostate volume
    Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
    Prostate volume
    Prostate volume measured by transrectal ultrasound. This examination is only performed at selected food-up visits (i.e. 6mo, 2y, 5y)
    Prostate specific antigen (PSA)
    laboratory test
    Prostate specific antigen (PSA)
    laboratory test
    Prostate specific antigen (PSA)
    laboratory test
    Prostate specific antigen (PSA)
    laboratory test
    Safety / adverse events
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Safety / adverse events
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Safety / adverse events
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Safety / adverse events
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Safety / adverse events
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    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.
    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.
    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.
    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.
    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.
    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).
    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).
    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).
    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).
    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).
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    assessed by patient interviews at follow up visit
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    assessed by patient interviews at follow up visit
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    assessed by patient interviews at follow up visit
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    assessed by patient interviews at follow up visit
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    assessed by patient interviews at follow up visit
    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.
    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.

    Full Information

    First Posted
    January 23, 2020
    Last Updated
    January 25, 2021
    Sponsor
    Dominik Abt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04245566
    Brief Title
    Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
    Acronym
    EMPATHY
    Official Title
    Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dominik Abt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia, Pharmacotherapy, Prostatic Artery Embolization, Minimally Invasive Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1 randomized controlled study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    425 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prostatic Artery Embolization (PAE)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Pharmocotherapy
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Prostatic Artery Embolization (PAE)
    Intervention Description
    Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
    Intervention Type
    Drug
    Intervention Name(s)
    Pharmacotherapy
    Intervention Description
    Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations
    Primary Outcome Measure Information:
    Title
    International Prostate Symptoms Score (IPSS)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    International Prostate Symptoms Score (IPSS)
    Description
    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
    Title
    International Prostate Symptoms Score (IPSS)
    Description
    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
    Title
    International Prostate Symptoms Score (IPSS)
    Description
    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
    Title
    International Prostate Symptoms Score (IPSS)
    Description
    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
    Title
    Self-assessed goal achievement (SAGA)
    Description
    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
    Title
    Self-assessed goal achievement (SAGA)
    Description
    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
    Title
    Self-assessed goal achievement (SAGA)
    Description
    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
    Title
    Self-assessed goal achievement (SAGA)
    Description
    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
    Title
    Self-assessed goal achievement (SAGA)
    Description
    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
    Title
    Maximum urinary stream (Qmax)
    Description
    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
    Title
    Maximum urinary stream (Qmax)
    Description
    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
    Title
    Maximum urinary stream (Qmax)
    Description
    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
    Title
    Maximum urinary stream (Qmax)
    Description
    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
    Title
    Maximum urinary stream (Qmax)
    Description
    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
    Title
    Post void residual urine (PVR)
    Description
    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
    Title
    Post void residual urine (PVR)
    Description
    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
    Title
    Post void residual urine (PVR)
    Description
    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
    Title
    Post void residual urine (PVR)
    Description
    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
    Title
    Post void residual urine (PVR)
    Description
    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
    Title
    Prostate volume
    Description
    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
    Title
    Prostate volume
    Description
    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
    Title
    Prostate volume
    Description
    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
    Title
    Prostate specific antigen (PSA)
    Description
    laboratory test
    Time Frame
    6 months after treatment initiation
    Title
    Prostate specific antigen (PSA)
    Description
    laboratory test
    Time Frame
    1 year after treatment initiation
    Title
    Prostate specific antigen (PSA)
    Description
    laboratory test
    Time Frame
    2 years after treatment initiation
    Title
    Prostate specific antigen (PSA)
    Description
    laboratory test
    Time Frame
    5 years after treatment initiation
    Title
    Safety / adverse events
    Description
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Time Frame
    6 weeks after treatment initiation
    Title
    Safety / adverse events
    Description
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Time Frame
    6 months after treatment initiation
    Title
    Safety / adverse events
    Description
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Time Frame
    1 year after treatment initiation
    Title
    Safety / adverse events
    Description
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Time Frame
    2 year after treatment initiation
    Title
    Safety / adverse events
    Description
    Number of patients developing adverse events: Classification will be performed according to Clavien-Dindo classification and CTCAE.
    Time Frame
    5 year after treatment initiation
    Title
    Erectile function
    Description
    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
    Title
    Erectile function
    Description
    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
    Title
    Erectile function
    Description
    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
    Title
    Erectile function
    Description
    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
    Title
    Erectile function
    Description
    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
    Title
    Ejaculatory function
    Description
    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
    Title
    Ejaculatory function
    Description
    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
    Title
    Ejaculatory function
    Description
    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
    Title
    Ejaculatory function
    Description
    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
    Title
    Ejaculatory function
    Description
    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
    Title
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    Description
    assessed by patient interviews at follow up visit
    Time Frame
    6 weeks after treatment initiation
    Title
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    Description
    assessed by patient interviews at follow up visit
    Time Frame
    6 moths after treatment initiation
    Title
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    Description
    assessed by patient interviews at follow up visit
    Time Frame
    1 year after treatment initiation
    Title
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    Description
    assessed by patient interviews at follow up visit
    Time Frame
    2 years after treatment initiation
    Title
    Need for additional drug treatment, surgical treatment or change of medical treatment assessed
    Description
    assessed by patient interviews at follow up visit
    Time Frame
    5 years after treatment initiation
    Title
    Analysis of cost-effectiveness using quality-adjusted life years (QALY)
    Description
    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
    Title
    Analysis of cost-effectiveness using quality-adjusted life years (QALY)
    Description
    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

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    based on presence of a prostate
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominik ABT, MD
    Phone
    41714941418
    Email
    dominik.abt@kssg.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dominik Abt, MD
    Organizational Affiliation
    Cantonal Hospital St. Gallen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.

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    Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH

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