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This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Artery Embolization | Experimental | Prostate Artery Embolization is a surgical procedure to relieve symptoms of Benign Prostatic Hyperplasia (BPH). Embolizing particles are injected into a target blood vessel to occlude blood flow. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate Artery Embolization | Device | Prostate Artery Embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Reported | All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported. | 3 Months |
| Change in International Prostate Symptom Score | The International Prostate Symptom Score assesses the severity of symptoms in benign prostatic hypertrophy. The questionnaire contains seven items rated on a scale from zero to five. Total scores are a sum of items scores and range from 0 to 35 with higher scores indicating worse BPH symptoms. Outcome is reported as the change in IPS score from baseline to three months. | baseline, 3 months |
| Change in Quality of Life Scale (QOLS) | Participants will complete the Quality of Life Scale (QOLS), which contains 15 items measuring five domains of quality of life. Total scores are a sum of item scores and range from 16 to 112, with higher scores indicating a better quality of life. | 3 months |
| Patient Reported Change in Medication Use | Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change | The Medical Therapy of Prostatic Symptoms (MTOPS) Outcome is reported as the number of participants who experience treatment efficacy as defined by an MTOPS composite variable symptom score greater than 30 and/or flow rate change of 15 millimeters per second or greater. | 3 months |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jafar Golzarian, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prostate Artery Embolization | Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants from whom data was collected are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prostate Artery Embolization | Prostate Artery Embolization Prostate Artery Embolization: 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, Categorical | Count of 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 | Number of Adverse Events Reported | All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported. | Posted | Number | adverse events | 3 Months |
|
|
12 months
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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 | Prostate Artery Embolization | Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jafar Golzarian, MD | University of Minnesota | 612-626-5566 | jafar@umn.edu |
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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 | May 24, 2017 | Sep 30, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2018 | Sep 10, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Change in International Prostate Symptom Score | The International Prostate Symptom Score assesses the severity of symptoms in benign prostatic hypertrophy. The questionnaire contains seven items rated on a scale from zero to five. Total scores are a sum of items scores and range from 0 to 35 with higher scores indicating worse BPH symptoms. Outcome is reported as the change in IPS score from baseline to three months. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months |
|
|
|
| Primary | Change in Quality of Life Scale (QOLS) | Participants will complete the Quality of Life Scale (QOLS), which contains 15 items measuring five domains of quality of life. Total scores are a sum of item scores and range from 16 to 112, with higher scores indicating a better quality of life. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | Patient Reported Change in Medication Use | Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported. | Measure was only collected from 2 participants. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change | The Medical Therapy of Prostatic Symptoms (MTOPS) Outcome is reported as the number of participants who experience treatment efficacy as defined by an MTOPS composite variable symptom score greater than 30 and/or flow rate change of 15 millimeters per second or greater. | Posted | Count of Participants | Participants | 3 months |
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| 0 |
| 5 |
| 1 |
| 5 |
| 4 |
| 5 |
| Burning Sensation While Urinating | Renal and urinary disorders | Systematic Assessment |
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| Post Procedure Penile Pain | Reproductive system and breast disorders | Systematic Assessment |
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| Blood in Urine | Renal and urinary disorders | Systematic Assessment |
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| D052801 |
| Male Urogenital Diseases |