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This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate artery embolization | Active Comparator |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate Artery Embolization | Procedure | Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score | A survey accessing patient symptomology from BPH induced LUTS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score | A survey accessing patient symptomology from BPH induced LUTS | 1, 3, 6, 9, 12, 24, 36 months |
| Quality of Life | A survey accessing quality of life impact on patients from BPH induced LUTS. |
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Inclusion Criteria:
• Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.
Exclusion Criteria:
• History of biopsy-proven prostate cancer
Imaging exclusion criteria:
• Internal iliac artery occlusion as determined by either CT or MRI.
Patients must be male, as they are the only ones who suffer from BPH induced LUTS
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pooja Doshi | Contact | 703-460-5580 | 580 | pdoshi@sirweb.org |
| Name | Affiliation | Role |
|---|---|---|
| Shamar Young, MD | University of Minnesota | Principal Investigator |
| Jafar Golzarian, MD | University of Minnesota | Principal Investigator |
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| 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 |
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Patients and those recording response will be blinded to cohort allocation.
| Sham Prostate Artery Embolization | Procedure | Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization. |
|
| 1, 3, 6, 9, 12, 24, 36 months |
| Maximal urinary flow rate change from baseline | Maximal flow rate of urine stream | 6, 12, 24, and 36 months |
| Post void residual change from baseline | Post void residual measures the volume of urine remaining in the bladder after complete emptying. | 6, 12, 24, and 36 months |
| International Index of Erectile Function questionnaire (IIEF) | A questionnaire designed to asses erectile function | 1, 3, 6, 9, 12, 24, 36 months |
| Freedom from secondary intervention to treat BPH | Recording of other surgical/procedural treatments with each procedure being recorded as an event. | 1, 3, 6, 9, 12, 24, 36 months |
| Ejaculatory function | Ejaculatory function will be assessed utilizing a four item questionnaire. | 3, 6, 9, 12, 24, 36 months |
| Urinary Continence | Urinary Continence will be assessed using a 2 item questionnaire | 1, 6, and 12 months |
| Number of hospital days | Number of hospital days following the procedure will be recorded | 1 month |
| Recover experience | Recover experience will be assessed using a quality of recovery visual analog scale | 1 month |
| Adverse events | All procedure related adverse events will be recoreded | 7 days and 1, 3, 6, 9, 12, 24, 36 months |
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |