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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy

Brief Summary:

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.

Detailed Summary: This will be an open label pilot study with a small population undergoing an intervention to determine safety and efficacy.
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

• Prostate size (grams) [ Time Frame: 1 year ]
  Reduction in size of the prostate to less than 80 grams
• Lower urinary symptoms (Arbitrary units) [ Time Frame: 1 year ]
  Improvement of LUTS as defined by IPSS score <18.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Procedure completion without complication (percentage) [ Time Frame: 1 year ]
  Completion of PAE without major complication
• Sexual Function (Arbitrary units) [ Time Frame: 1 year ]
  Stability or improvement of sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire
• Quality of Life (Arbitrary units) [ Time Frame: 1 year ]
  Improvement of quality of life as determined by an improved score on Quality of Life questionnaire

Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: June 17, 2014
Date Started: July 2014
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017