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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate artery embolization | Device | Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Only males can receive prostatic artery embolization
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Men with lower urinary tract sypmtoms (LUTS) due to benign prostatic hyperplasia (BPH)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare Systems | Long Beach | California | 90822 | United States | ||
| Ronald Reagan UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39230672 | Derived | Sapoval MR, Bhatia S, Dean C, Rampoldi A, Carnevale FC, Bent C, Tapping CR, Bongiovanni S, Taylor J, Brower JS, Rush M, McWilliams JP, Little MW; PROstate Study Investigators. Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study. Cardiovasc Intervent Radiol. 2024 Nov;47(11):1515-1524. doi: 10.1007/s00270-024-03802-0. Epub 2024 Sep 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2022 |
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| 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
| 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 |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| UC Irvine Health | Orange | California | 92868 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| University of Miami- Miller School of Medicine | Miami | Florida | 33136 | United States |
| St. Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Providence Sacred Heart | Spokane | Washington | 99204 | United States |
| Hôspital Européan Georges Pompidou HEGP | Paris | 75015 | France |
| Azienda Ospedaliera S. Croce e Carle Cuneo | Cuneo | 12100 | Italy |
| Ospedale Niguarda Ca' Granda | Milan | 20162 | Italy |
| Churchill Hospital | Headington | Oxford | OX3 7LE | United Kingdom |
| Frimley Park Hospital | Camberley | Surrey | GU16 7UJ | United Kingdom |
| Royal Bournemouth and Christchurch Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Royal Berkshire Hospital | Reading | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | scores on scale | 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. | Posted | Mean | 95% Confidence Interval | scores on scale | 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. | Posted | Mean | 95% Confidence Interval | scores on scale | 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
| Posted | Count of Participants | Participants | 3, 12, 24 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE. | Posted | Count of Participants | Participants | 3, 12, 24 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Technical Success Defined as Successful Embolization of the Treated Prostate Gland. | Posted | Count of Participants | Participants | 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). | Posted | Count of Participants | Participants | 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. | Posted | Mean | 95% Confidence Interval | scores on scale | 12 Months |
|
|
24 Months
Results in death Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 487 | 10 | 487 | 57 | 487 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Blood in urine | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dizziness upon walking | General disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea and congestive heart failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Emergency admission with abdominal pain and vomiting | General disorders | MedDRA | Systematic Assessment |
| |
| False aneurysm at point of puncture | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Prostatitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection and hypotension | Infections and infestations | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal spasm | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Acute retention of urine | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Blood in stool | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bowel incontinence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Fever | General disorders | MedDRA | Systematic Assessment |
| |
| Low Grade Fever | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Bladder inability to empty | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Burning micturition | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Contracted bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Frequency urinary | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Incontinence urinary | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Painful urination | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Unable to urinate | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urgency urination | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary catheterization | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Bloody semen | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Rectoprostatic fistula | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Holland | Merit Medical | 6178420251 | casey.holland@merit.com |
| May 5, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
| France |
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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 3 Months |
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| 12 Months |
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| 24 Months |
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