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Prostate Embolization for Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924988
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : November 27, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
James B. Spies, MD, Georgetown University

Brief Summary:
This is a Phase I/II investigator sponsored FDA-approved Investigational Device Exemption protocol, with the primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary goal is to document the frequency of side effects, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will provide preliminary data to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Prostatic Embolization with Embosphere Micropsheres Phase 1 Phase 2

Detailed Description:

Objectives of the investigation

This study has a primary goal of determining the safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia. Our primary outcome is the frequency of adverse events, particularly bladder and rectal complications, which may occur as a result of this procedure. Secondarily, the study will allow us to begin to determine its effectiveness in diminishing obstructive symptoms associated with BPH.

Duration of investigation

The investigation will enroll 30 patients, with a target enrollment period of less than 12 months. Each patient will be consented for follow-up up to 5 years, but each patient will reach the first important safety endpoint 1 week after treatment and the first clinical efficacy assessment 3 months after treatment.

Objectives

To determine the safety and effectiveness of prostate artery embolization for the treatment of BPH.

Description of study type

This is a prospective non-comparative treatment study of an initial cohort of 30 patients.

Study Population

The patients will be recruited from the urology practice at Georgetown University and from other urologists in the area and by patient self-referral. The study also will be announced on a study website, the content of which will be approved by the IRB at Georgetown University Medical Center.

The primary outcome is the absence of complications to the bladder, rectum or other pelvic structures detected in the first week after therapy. Each patient will be judged free of these adverse events or not. For those with an adverse event, the complication will be scored using the Society of Interventional Radiology (SIR) definitions. Descriptive statistics will be used to summarize these events, along with patient demographics and initial clinical status.

Appropriate parametric and non-parametric tests will be used to assess change in laboratory measures, urine flowmetry parameters, and scores from the IPSS and IIEF. Changes in prostate volumes and the estimated volume of devascularized tissue will be calculated for each patient and outcomes from the different embolics will be compared. Appropriate paired parametric and non-parametric tests will be used to determine statistical significance. A p value of 0.05 will be considered statistically significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Embolization for Benign Prostatic Hyperplasia
Study Start Date : August 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prostatic Embolization
Therapeutic occlusion of the prostate arteries
Device: Prostatic Embolization with Embosphere Micropsheres

Each patient will have a selective internal iliac arteriogram, and as necessary, an arteriogram of the anterior division of the internal iliac artery performed to identify the prostatic arterial supply. This typically arises from the inferior vesicle artery (also known as the prostatic artery), but may have supply from the superior vesicle, the internal pudendal or obturator branches as well.

The prostatic arteries will be selected using standard micro-catheter technique. Embolization of the prostate will be performed with 300 to 500 um sized TAGM (Embosphere® Microspheres, Merit Medical, South Jordan, UT). The embolization endpoint will be absence of the normal blush of the prostate on post embolization angiography and stasis of flow in the prostate arteries.





Primary Outcome Measures :
  1. Number of Participants With Bladder or Rectal Injury [ Time Frame: Evaluated 1 week after procedure ]
    Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.

  2. Detection of Bladder Injury [ Time Frame: 3 months after treatment ]
    Bladder injury as detected by cystoscopy

  3. Detection of a Bladder Injury [ Time Frame: 6 months after treatment ]
    Bladder injury detected by cystoscopy

  4. Detection of a Bladder Injury by Cystoscopy [ Time Frame: 12 months after the procedure ]
    Number of patients with a bladder injury detected by cystoscopic examination


Secondary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 1week, 3 months, 6months, 12months ]
    Measure Description: Validated patient reported questionnaire to assess the severity of lower urinary tract symptoms associated with benign prostatic enlargement. Severity of symptom scores range from 0 to 35, with a score of 0-7 considered mild, 8-19 moderate and 20 to 35 severe symptoms.

  2. International Index of Erectile Function (IIEF)- 5 [ Time Frame: 1week, 3 months, 6months, 12months ]
    Measure Description: IIEF-5 is a 5 question validated patient reported outcome measure or erectile dysfunction (ED), with a range of scores from 5 to 25, and ED was classified into five categories or erectile function based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

  3. QMax (Peak Urinary Flow) [ Time Frame: 1week, 3 months, 6months, 12months ]
    Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. You must have symptoms from BPH for at least 6 months
  2. Your symptoms must meet the entrance criteria, as determined by a short questionnaire you will be asked to complete.
  3. You must have urinary flow rates that meet entrance criteria, as measured by a simple urination test.
  4. Enlargement of the prostate, as measured by the urologist, with a volume of between 50 and 100 cc.
  5. You must be at least 50 years of age, but not more than 90.

Exclusion Criteria:

  • 1. Prostate Cancer 2. Blockage of major arteries in your pelvis or other arterial abnormalities that prevent embolization or that might increase risks of injury. You will be screened for these conditions if you consent to participate.

    3. Significantly decreased kidney function 4. Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery.

    5. Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate.

    6. History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression.

    7. History of clotting disorders. 8. Current medications (use of alpha-blockers within two months, 5-alpha-reductase inhibitors within six months, anti-cholinergics within two months, and beta blockers, antihistamines, anticonvulsants, or antispasmodics within one week of treatment unless you have been on the same drug with a stable urination pattern.

    9. Active urinary tract infection 10. Allergy to iodinated contrast agents, collagen or gelatin products 11. Acute urinary retention that has NOT been treated by a urinary catheter. 12. Significant retained urine after voiding as measured by ultrasound. In this case, significant means more than 250 ml (about 1 cup).

    13. Bladder stones or blood in urine within three months 14. Previous rectal surgery, excluding hemorrhoidectomy (removal of hemorrhoid), or history of rectal disease 15. Prior pelvic irradiation or radical pelvic surgery 16. If you are interested in future fertility 17. Unable to speak and read English.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924988


Locations
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United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
James B. Spies, MD
  Study Documents (Full-Text)

Documents provided by James B. Spies, MD, Georgetown University:
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Responsible Party: James B. Spies, MD, Chair, Department of Radiology, Georgetown University
ClinicalTrials.gov Identifier: NCT01924988    
Other Study ID Numbers: G120110
First Posted: August 19, 2013    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: December 10, 2019
Last Verified: November 2019
Keywords provided by James B. Spies, MD, Georgetown University:
BPH, benign prostatic hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases