Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Prostatic Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), Embolization, Embolic, Embosphere Microsphere
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.
Interventions
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
Sponsors
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE. | 3, 12, 24 Months | — |
| 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. |
| 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. |
| Technical Success Defined as Successful Embolization of the Treated Prostate Gland. | Day of PAE Procedure | — |
Countries
France, Italy, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated With Embosphere Microspheres 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).
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. | 487 |
| Total | 487 |
Baseline characteristics
| Characteristic | Treated With Embosphere Microspheres |
|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 8.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 283 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 192 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 147 Participants |
| Race (NIH/OMB) White | 332 Participants |
| Region of Enrollment France | 135 participants |
| Region of Enrollment Italy | 127 participants |
| Region of Enrollment United Kingdom | 122 participants |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 487 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 487 |
| other Total, other adverse events | 57 / 487 |
| serious Total, serious adverse events | 10 / 487 |
Outcome results
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
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated With Embosphere Microspheres | Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS). | -11.1 scores on scale |
Secondary
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
Time frame: 3, 12, 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated With Embosphere Microspheres | Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE). | 24 Months | 10 Participants |
| Treated With Embosphere Microspheres | Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE). | 3 Months | 20 Participants |
| Treated With Embosphere Microspheres | Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE). | 12 Months | 22 Participants |
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated With Embosphere Microspheres | Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM). | -0.1 scores on scale |
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 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.
Time frame: 3, 12, 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated With Embosphere Microspheres | Device or Procedure Related Adverse Events Post Procedure. | 24 Months | 0 Participants |
| Treated With Embosphere Microspheres | Device or Procedure Related Adverse Events Post Procedure. | 3 Months | 0 Participants |
| Treated With Embosphere Microspheres | Device or Procedure Related Adverse Events Post Procedure. | 12 Months | 0 Participants |
Secondary
Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
Time frame: 3, 12, 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated With Embosphere Microspheres | Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE. | 3 Months | 55 Participants |
| Treated With Embosphere Microspheres | Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE. | 12 Months | 0 Participants |
| Treated With Embosphere Microspheres | Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE. | 24 Months | 0 Participants |
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.
Time frame: 3, 24 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treated With Embosphere Microspheres | International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE. | 3 Months | -12.4 scores on scale |
| Treated With Embosphere Microspheres | International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE. | 24 Months | -10.1 scores on scale |
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.
Time frame: 3, 24 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treated With Embosphere Microspheres | 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 Months | -2.7 scores on scale |
| Treated With Embosphere Microspheres | 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. | 24 Months | -2.4 scores on scale |
Secondary
Technical Success Defined as Successful Embolization of the Treated Prostate Gland.
Time frame: Day of PAE Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated With Embosphere Microspheres | Technical Success Defined as Successful Embolization of the Treated Prostate Gland. | 432 Participants |