Clinical trial NCT02167919: Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)
Official title: Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostate
Men
Hyperplasia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 15
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prostate size (grams)
timeFrame: 1 year
measure: Lower urinary symptoms (Arbitrary units)
timeFrame: 1 year
Secondary outcomes:
measure: Procedure completion without complication (percentage)
timeFrame: 1 year
measure: Sexual Function (Arbitrary units)
timeFrame: 1 year
measure: Quality of Life (Arbitrary units)
timeFrame: 1 year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ari Isaacson, MD
role: PRINCIPAL_INVESTIGATOR
References: