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

University of North Carolina (UNC)

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: Microspheres

Study type

Interventional

Funder types

Other

Identifiers

NCT02167919

13-3445

Details and patient eligibility

About

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.

Full description

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

Enrollment

15 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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