Embosphere® PROstate Post Market Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres

Conditions
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Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Prostate artery embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with Embosphere Microspheres<br>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). | Device: Prostate artery embolization<br>* Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS). | 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 | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE. | 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. | 3, 24 Months | 
| 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. | 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. | 3, 24 Months | 
| Device or Procedure Related Adverse Events Post Procedure. | 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 had an event within (on or before) the reporting cutoff days, or had a follow-up at or after the lower limit of the reporting window, or the withdrawal consent date/recorded lost-to-follow-up date at or after the lower limit of the reporting window. | 3, 12, 24 Months | 
| 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 | 
| 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). | 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. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), Embolization, Embolic, Embosphere Microsphere