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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microspheres
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Benign Prostatic Hyperplasia focused on measuring Prostate, Men, Hyperplasia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostatic artery embolization

Arm Description

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

Outcomes

Primary Outcome Measures

Prostate size (grams)
Reduction in size of the prostate to less than 80 grams
Lower urinary symptoms (Arbitrary units)
Improvement of LUTS as defined by IPSS score <18.

Secondary Outcome Measures

Procedure completion without complication (percentage)
Completion of PAE without major complication
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
Quality of Life (Arbitrary units)
Improvement of quality of life as determined by an improved score on Quality of Life questionnaire

Full Information

First Posted
June 17, 2014
Last Updated
September 13, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT02167919
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Prostate, Men, Hyperplasia

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostatic artery embolization
Arm Type
Experimental
Arm Description
Microspheres measuring 100-300 microns will be injected under fluoroscopic guidance into the left and right prostatic arteries for embolization.
Intervention Type
Device
Intervention Name(s)
Microspheres
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prostate size (grams)
Description
Reduction in size of the prostate to less than 80 grams
Time Frame
1 year
Title
Lower urinary symptoms (Arbitrary units)
Description
Improvement of LUTS as defined by IPSS score <18.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Procedure completion without complication (percentage)
Description
Completion of PAE without major complication
Time Frame
1 year
Title
Sexual Function (Arbitrary units)
Description
Stability or improvement of sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire
Time Frame
1 year
Title
Quality of Life (Arbitrary units)
Description
Improvement of quality of life as determined by an improved score on Quality of Life questionnaire
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Isaacson, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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