Clinical trial NCT01924988: Prostate Embolization for Benign Prostatic Hyperplasia
Official title: Prostate Embolization for Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH, benign prostatic hyperplasia
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 15
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Bladder or Rectal Injury
timeFrame: Evaluated 1 week after procedure
measure: Detection of Bladder Injury
timeFrame: 3 months after treatment
measure: Detection of a Bladder Injury
timeFrame: 6 months after treatment
measure: Detection of a Bladder Injury by Cystoscopy
timeFrame: 12 months after the procedure
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 1week, 3 months, 6months, 12months
measure: International Index of Erectile Function (IIEF)- 5
timeFrame: 1week, 3 months, 6months, 12months
measure: QMax (Peak Urinary Flow)
timeFrame: 1week, 3 months, 6months, 12months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
Study officials:
References: