Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH)
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Benign Prostate Hyperplasia, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 9/15/2017 |
| Start Date: | July 2014 |
| End Date: | May 1, 2017 |
Efficacy of Prostatic Artery Embolization (PAE) in Patients With Severe Benign Prostatic Hyperplasia (BPH) As an Alternative to Open Prostatectomy
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.
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.
This will be an open label pilot study with a small population undergoing an intervention to
determine safety and efficacy.
determine safety and efficacy.
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
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