Prostate Embolization for Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption protocol, with the primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side effects, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will provide preliminary data to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

Detailed Description
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Objectives of the investigation This study has a primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary outcome is the frequency of adverse events, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will allow us to begin to determine its effectiveness in diminishing obstructive symptoms associated with BPH. Duration of investigation The investigation will enroll 30 patients, with a target enrollment period of less than 12 months. Each patient will be consented for follow-up up to 5 years, but each patient will reach the first important safety endpoint 1 week after treatment and the first clinical efficacy assessment 3 months after treatment. Objectives To determine the safety and effectiveness of prostate artery embolization for the treatment of BPH. Description of study type This is a prospective non-comparative treatment study of an initial cohort of 30 patients. Study Population The patients will be recruited from the urology practice at Georgetown University and from other urologists in the area and by patient self-referral. The study also will be announced on a study website, the content of which will be approved by the IRB at Georgetown University Medical Center. The primary outcome is the absence of complications to the bladder, rectum or other pelvic structures detected in the first week after therapy. Each patient will be judged free of these adverse events or not. For those with an adverse event, the complication will be scored using the Society of Interventional Radiology (SIR) definitions. Descriptive statistics will be used to summarize these events, along with patient demographics and initial clinical status. Appropriate parametric and non-parametric tests will be used to assess change in laboratory measures, urine flowmetry parameters, and scores from the IPSS and IIEF. Changes in prostate volumes and the estimated volume of devascularized tissue will be calculated for each patient and outcomes from the different embolics will be compared. Appropriate paired parametric and non-parametric tests will be used to determine statistical significance. A p value of 0.05 will be considered statistically significant.

Official Title
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Prostate Embolization for Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Prostatic Embolization with Embosphere Micropsheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You must have symptoms from BPH for at least 6 months Your symptoms must meet the entrance criteria, as determined by a short questionnaire you will be asked to complete. You must have urinary flow rates that meet entrance criteria, as measured by a simple urination test. Enlargement of the prostate, as measured by the urologist, with a volume of between 50 and 100 cc. You must be at least 50 years of age, but not more than 90. Exclusion Criteria: 1. Prostate Cancer 2. Blockage of major arteries in your pelvis or other arterial abnormalities that prevent embolization or that might increase risks of injury. You will be screened for these conditions if you consent to participate. 3. Significantly decreased kidney function 4. Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery. 5. Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate. 6. History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression. 7. History of clotting disorders. 8. Current medications (use of alpha-blockers within two months, 5-alpha-reductase inhibitors within six months, anti-cholinergics within two months, and beta blockers, antihistamines, anticonvulsants, or antispasmodics within one week of treatment unless you have been on the same drug with a stable urination pattern. 9. Active urinary tract infection 10. Allergy to iodinated contrast agents, collagen or gelatin products 11. Acute urinary retention that has NOT been treated by a urinary catheter. 12. Significant retained urine after voiding as measured by ultrasound. In this case, significant means more than 250 ml (about 1 cup). 13. Bladder stones or blood in urine within three months 14. Previous rectal surgery, excluding hemorrhoidectomy (removal of hemorrhoid), or history of rectal disease 15. Prior pelvic irradiation or radical pelvic surgery 16. If you are interested in future fertility 17. Unable to speak and read English.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostatic Embolization<br>Therapeutic occlusion of the prostate arteries | Device: Prostatic Embolization with Embosphere Micropsheres<br>* Each patient will have a selective internal iliac arteriogram, and as necessary, an arteriogram of the anterior division of the internal iliac artery performed to identify the prostatic arterial supply. This typically arises from the inferior vesicle artery (also known as the prostatic artery), but may have supply from the superior vesicle, the internal pudendal or obturator branches as well. The prostatic arteries will be selected using standard micro-catheter technique. Embolization of the prostate will be performed with 300 to 500 um sized TAGM (Embosphere® Microspheres, Merit Medical, South Jordan, UT). The embolization endpoint will be absence of the normal blush of the prostate on post embolization angiography and stasis of flow in the prostate arteries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Bladder or Rectal Injury | Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy. | Evaluated 1 week after procedure | 
| Detection of Bladder Injury | Bladder injury as detected by cystoscopy | 3 months after treatment | 
| Detection of a Bladder Injury | Bladder injury detected by cystoscopy | 6 months after treatment | 
| Detection of a Bladder Injury by Cystoscopy | Number of patients with a bladder injury detected by cystoscopic examination | 12 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | Measure Description: Validated patient reported questionnaire to assess the severity of lower urinary tract symptoms associated with benign prostatic enlargement. Severity of symptom scores range from 0 to 35, with a score of 0-7 considered mild, 8-19 moderate and 20 to 35 severe symptoms. | 1week, 3 months, 6months, 12months | 
| International Index of Erectile Function (IIEF)- 5 | Measure Description: IIEF-5 is a 5 question validated patient reported outcome measure or erectile dysfunction (ED), with a range of scores from 5 to 25, and ED was classified into five categories or erectile function based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25). | 1week, 3 months, 6months, 12months | 
| QMax (Peak Urinary Flow) | Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec. | 1week, 3 months, 6months, 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, benign prostatic hyperplasia