Benign Prostatic Hyperplasia Clinical Trial
— PROstateOfficial title:
A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres
Verified date | December 2023 |
Source | Merit Medical Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Merit Medical Systems, Inc. |
United States, France, Italy, United Kingdom,
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 |
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