Prostate Embolization for Benign Prostatic Hyperplasia
Prostate Embolization for Benign Prostatic Hyperplasia
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.
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.
Inclusion Criteria:

 1. You must have symptoms from BPH for at least 6 months

 2. Your symptoms must meet the entrance criteria, as determined by a short questionnaire
 you will be asked to complete.

 3. You must have urinary flow rates that meet entrance criteria, as measured by a simple
 urination test.

 4. Enlargement of the prostate, as measured by the urologist, with a volume of between 50
 and 100 cc.

 5. 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.