Prostate Embolization for Benign Prostatic Hyperplasia

Completed · Phase 1/Phase 2

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT01924988

Run by

James B. Spies, MD

People needed

15

Starts

2013-08-01

Expected to finish

2017-04-01

Last updated by the study team

2019-12-10

Who can join

Age: 50 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Significantly decreased kidney function 4. Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery.
• Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate.
• History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression.
• 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.
• 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).
• 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.

Where it is running

• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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