Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH

Benign Prostatic Hyperplasia Clinical Trial

— EMPATHY  

Official title:

Prostatic Artery Embolization vs. Pharmacotherapy for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04245566
• Other study ID #: CTU19/025
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2021
• Source: Cantonal Hospital of St. Gallen
• Contact: Dominik ABT, MD
• Phone: 41714941418
• Email: dominik.abt[@]kssg.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 425
• Est. completion date: December 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 100 Years

Eligibility

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 a-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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Minimally Invasive Treatment
• Pharmacotherapy
• Prostatic Artery Embolization
• Prostatic Hyperplasia

Intervention

Procedure:
• Prostatic Artery Embolization (PAE)
Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.

Drug:
• Pharmacotherapy
Pharmacotherapy will be performed using a1-blockers and 5a-reductase inhibitors in accordance with the EAU recommendations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dominik Abt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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 months after treatment initiation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prostate specific antigen (PSA)	laboratory test	6 months after treatment initiation
Secondary	Prostate specific antigen (PSA)	laboratory test	1 year after treatment initiation
Secondary	Prostate specific antigen (PSA)	laboratory test	2 years after treatment initiation
Secondary	Prostate specific antigen (PSA)	laboratory test	5 years after treatment initiation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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