NCT02167919

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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 description

This will be an open label pilot study with a small population undergoing an intervention to determine safety and efficacy.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Microspheres	Prostatic artery embolization (PAE) is a new procedure that decreases the size of the prostate by blocking its arterial blood flow. Through a tiny puncture in the upper thigh or forearm a catheter is directed to the prostatic artery using fluoroscopic guidance. Once in place, sub-millimeter particles are injected that obstruct the prostatic arteries resulting in gland ischemia, and ultimately, reduction in size. The technique has only been recently developed in Portugal and Brazil and has similarities to Uterine Artery Embolization used to treat uterine fibroids.

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-06-19
• Last updated: 2017-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study