Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)

Completed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

Purpose: To evaluate the efficacy of prostatic artery embolization (PAE) in patients with benign prostatic hyperplasia (BPH) and refractory lower urinary tract symptoms (LUTS) in decreasing the volume of the prostate gland. Participants: Study participants will be recruited from UNC Urology clinics as well as referring providers. We will include 15 men who are experiencing LUTS not controlled by medication with estimated prostate gland weight between 80 and 150 grams. Procedures (methods): Enrolled patients will undergo the standard work-up for a surgical prostate procedure. In addition, the patient's arteries will be evaluated with a pelvic CT angiogram. Then, patients will undergo prostatic artery embolization. Follow up visits will be scheduled at 1, 3, 6, and 12 months after the procedure. At the end of the follow-up period, if reduction in prostate gland size has made the patient eligible for transurethral therapy, they may proceed to such procedure or elect to undergo no further surgical procedure, depending on residual symptoms. Similarly, if insufficient gland size reduction has occurred, the patient may elect to pursue OP or no further procedure if they are no longer bothered by LUTS.

Key facts

Study ID

NCT02167919

Run by

University of North Carolina, Chapel Hill

People needed

15

Starts

2014-07-01

Expected to finish

2017-05-01

Last updated by the study team

2017-09-14

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male
• Age > 40
• Prostate gland measures between 80 and 150 grams
• Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
• Moderate to severe LUTS as defined by IPSS score >18
• Peak urine flow rate (Qmax) <12 ml/sec
• Capable of giving informed consent
• Life expectancy greater than 1 year

You may not qualify if…

• Severe cardiac or pulmonary disease
• Uncontrolled diabetes mellitus
• Immunosuppression
• Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
• Acute urinary retention
• Glomerular filtration rate less than 45 as approximated using using serum creatinine levels.
• Confirmed or suspected bladder cancer
• Recent (within 3 months) cystolithiasis or gross hematuria
• Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
• Active urinary tract infection
• Previous rectal surgery or history of rectal disease if PAE, anoscopy or transrectal ultrasound are thought to potentially cause injury to the rectum due to the previous surgery or disease
• Previous pelvic radiation or radical pelvic surgery
• Confirmed or suspected malignancy of the prostate based on DRE, TRUS or PSA. (> 10 ng/ml or > 2.5 ng/ml and < 10 ng/ml with free PSA < 25% of total PSA without a negative biopsy)
• Uncorrectable coagulopathy including INR > 2.5 or platelets < 30,000

Where it is running

• UNC Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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