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

NCT ID: NCT02167919

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-05-01

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Prostatic artery embolization

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

Group Type: EXPERIMENTAL

Microspheres

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ari Isaacson, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Hospitals

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-3445

Identifier Type: -

Identifier Source: org_study_id