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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: Microspheres

• Registration Number: NCT02167919
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Description

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

Study Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Study Start: 2014-07
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostatic artery embolization	Microspheres	Microspheres measuring 100-300 microns will be injected under fluoroscopic guidance into the left and right prostatic arteries for embolization.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Procedure completion without complication (percentage)	1 year	Completion of PAE without major complication
Sexual Function (Arbitrary units)	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)	1 year	Improvement of quality of life as determined by an improved score on Quality of Life questionnaire

Trial Locations

Locations (1)

UNC Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States