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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167919
• Other study ID #: 13-3445
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: September 13, 2017
• Start date: July 2014
• Est. completion date: May 1, 2017

Study information

• Verified date: September 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate size (grams)	Reduction in size of the prostate to less than 80 grams	1 year
Primary	Lower urinary symptoms (Arbitrary units)	Improvement of LUTS as defined by IPSS score <18.	1 year
Secondary	Procedure completion without complication (percentage)	Completion of PAE without major complication	1 year
Secondary	Sexual Function (Arbitrary units)	Stability or improvement of sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire	1 year
Secondary	Quality of Life (Arbitrary units)	Improvement of quality of life as determined by an improved score on Quality of Life questionnaire	1 year