Embosphere® PROstate Post Market Study

Benign Prostatic Hyperplasia Clinical Trial

— PROstate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527589
• Other study ID #: PAE-P4-17-01
• Status: Completed
• Start date: August 16, 2018
• Est. completion date: January 22, 2022

Study information

• Verified date: December 2023
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: January 22, 2022
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Prostate artery embolization
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

United States,  France,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.		3, 12, 24 Months
Secondary	Technical Success Defined as Successful Embolization of the Treated Prostate Gland.		Day of PAE Procedure
Secondary	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
Secondary	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