Clinical trial NCT03527589: Embosphere® PROstate Post Market Study
Official title: A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Prostatic Artery Embolization (PAE)
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
Embolization
Embolic
Embosphere Microsphere
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-17
Enrollment: 499
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with lower urinary tract sypmtoms (LUTS) due to benign prostatic hyperplasia (BPH)

Brief summary: Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

Detailed description: This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months and 24 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.

Eligibility criteria: Inclusion Criteria:

* Patient has signed informed consent
* Patient age is 18 years or older at time of informed consent
* Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms

Exclusion Criteria:

* Patient is unable or unwilling to provide follow-up information
* Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
* Any other reason the investigator deems cause for exclusion

Primary outcomes:
measure: Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).
timeFrame: 12 Months
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.
timeFrame: 3, 24 Months
measure: Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.
timeFrame: 3, 24 Months
measure: Device or Procedure Related Adverse Events Post Procedure.
timeFrame: 3, 12, 24 Months
measure: Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
timeFrame: 3, 12, 24 Months
measure: Technical Success Defined as Successful Embolization of the Treated Prostate Gland.
timeFrame: Day of PAE Procedure
measure: Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
timeFrame: 3, 12, 24 Months
measure: Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM).
timeFrame: 12 Months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare Systems
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami- Miller School of Medicine
state: Florida
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Spokane
country: United States
facility: Providence Sacred Heart
state: Washington
city: Paris
country: France
facility: Hôspital Européan Georges Pompidou HEGP
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle Cuneo
city: Milano
country: Italy
facility: Ospedale Niguarda Ca' Granda
city: Headington
country: United Kingdom
facility: Churchill Hospital
state: Oxford
city: Camberley
country: United Kingdom
facility: Frimley Park Hospital
state: Surrey
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth and Christchurch Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
Study officials:
References: