Embosphere® PROstate Post Market Study

Completed

Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia

Interventions: Device: Prostate artery embolization

Registration Number: NCT03527589

Lead Sponsor: Merit Medical Systems, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 499

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated with Embosphere Microspheres	Prostate artery embolization	Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).

Primary Outcome Measures

Name	Time	Method
Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).	12 Months	The two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores on a scale' is the unite of measure

Secondary Outcome Measures

Name	Time	Method
Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.	3, 12, 24 Months
Technical Success Defined as Successful Embolization of the Treated Prostate Gland.	Day of PAE Procedure
International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.	3, 24 Months	The time points used in the calculation were baseline, 3 months and 24 months. The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints). The same calculation was also done at 24 months. From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores' on a scale is the unite of 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.	3, 24 Months	The time points used in the calculation were baseline, 3 months and 24 months. The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints). The same calculation was also done at 24 months. From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Device or Procedure Related Adverse Events Post Procedure.	3, 12, 24 Months	The measure used to assess "device or procedure related adverse events post procedure" at three different time points (3, 12, 24 months) are frequencies and percentages. For each visit (or reporting time point), the event rate will be calculated as the number of subjects with certain event terms over the number of evaluable subjects. The evaluable subjects at each reporting time point include all subjects who are enrolled and 1. had an event within (on or before) the reporting cutoff days, or 2. had a follow-up at or after the lower limit of the reporting window, or 3. the withdrawal consent date/recorded lost-to-follow-up date at or after the lower limit of the reporting window.
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).	3, 12, 24 Months
Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM).	12 Months	The calculation was done using the 12 months mean Sexual Health Inventory for Men (SHIM) score minus the baseline mean SHIM score for paired data (e.g., available data on both baseline and 12 month timepoints). From the SHIM questionnaire, the total scores was used and range from 1 to 25 with higher scores representing better outcomes (no signs of erectile dysfunction) and lower scores representing worse outcomes (severe erectile dysfunction). There are a total of 5 questions on the scale and the scores from each question are summed to get a total score. A positive change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.

Trial Locations

Locations (15): Frimley Park Hospital
🇬🇧
Camberley, Surrey, United Kingdom
Royal Bournemouth and Christchurch Hospital
🇬🇧
Bournemouth, United Kingdom
University of Miami- Miller School of Medicine
🇺🇸
Miami, Florida, United States
Azienda Ospedaliera S. Croce e Carle Cuneo
🇮🇹
Cuneo, Italy
Hôspital Européan Georges Pompidou HEGP
🇫🇷
Paris, France
Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
Ospedale Niguarda Ca' Granda
🇮🇹
Milano, Italy
Providence Sacred Heart
🇺🇸
Spokane, Washington, United States
UC Irvine Health
🇺🇸
Orange, California, United States
Royal Berkshire Hospital
🇬🇧
Reading, United Kingdom
University of California Los Angeles
🇺🇸
Los Angeles, California, United States
St. Louis University Hospital
🇺🇸
Saint Louis, Missouri, United States
Ronald Reagan UCLA Medical Center
🇺🇸
Los Angeles, California, United States
VA Long Beach Healthcare Systems
🇺🇸
Long Beach, California, United States
Churchill Hospital
🇬🇧
Headington, Oxford, United Kingdom