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

NCT02167919 | Completed FDA Device

• 1 other identifier: 13-3445
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Prostate; Men; Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Prostate size (grams)

  Reduction in size of the prostate to less than 80 grams

  1 year

• Lower urinary symptoms (Arbitrary units)

  Improvement of LUTS as defined by IPSS score \<18.

  1 year

Secondary Outcomes (3)

• Procedure completion without complication (percentage)

  1 year

• Sexual Function (Arbitrary units)

  1 year

• Quality of Life (Arbitrary units)

  1 year

Study Arms (1)

Prostatic artery embolization

EXPERIMENTAL

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

Device: Microspheres

Interventions

Microspheres 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.

Prostatic artery embolization

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Multiple Endocrine Neoplasia Type 1; Hyperplasia

Interventions

Microspheres

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Ari Isaacson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)