Prostate Embolization for Benign Prostatic Hyperplasia

NCT01924988 | Completed Phase 1 Results

• 1 other identifier: G120110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH, benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Bladder or Rectal Injury

  Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.

  Evaluated 1 week after procedure

• Detection of Bladder Injury

  Bladder injury as detected by cystoscopy

  3 months after treatment

• Detection of a Bladder Injury

  Bladder injury detected by cystoscopy

  6 months after treatment

• Detection of a Bladder Injury by Cystoscopy

  Number of patients with a bladder injury detected by cystoscopic examination

  12 months after the procedure

Secondary Outcomes (3)

• International Prostate Symptom Score (IPSS)

  1week, 3 months, 6months, 12months

• International Index of Erectile Function (IIEF)- 5

  1week, 3 months, 6months, 12months

• QMax (Peak Urinary Flow)

  1week, 3 months, 6months, 12months

Study Arms (1)

Prostatic Embolization

EXPERIMENTAL

Therapeutic occlusion of the prostate arteries

Device: Prostatic Embolization with Embosphere Micropsheres

Interventions

Prostatic Embolization with Embosphere Micropsheres DEVICE

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.

Prostatic Embolization

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. Significantly decreased kidney function 4. Prior prostate surgery, whether it has been performed via a scope through the penis or with conventional surgery.
• \. Bladder or urinary conditions other than BPH requiring therapy. You will be screened for these conditions if you consent to participate.
• \. History of cardiac rhythm abnormalities, congestive heart failure, uncontrolled diabetes, significant respiratory disease, or known immunosuppression.
• \. 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.
• \. 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).
• \. 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.

Sponsors & Collaborators

• James B. Spies, MD: lead

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

There as poor compliance by patients to the follow-up protocol beyond 1 week post procedure. Only 10 of 15 patients participated in follow-up at three months. By 12 months, only 3 patients provided some elements of follow-up.

Results Point of Contact

• Title: James B. Spies MD MPH
• Organization: Georgetown University Medical Center

spiesj@gunet.georgetown.edu

202-444-3450

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Department of Radiology

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 19, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 10, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)