Benign Prostatic Hyperplasia
Conditions
Keywords
BPH, benign prostatic hyperplasia
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.
Interventions
DEVICEProstatic 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.
Sponsors
James B. Spies, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bladder or Rectal Injury | Evaluated 1 week after procedure | Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy. |
| Detection of Bladder Injury | 3 months after treatment | Bladder injury as detected by cystoscopy |
| Detection of a Bladder Injury | 6 months after treatment | Bladder injury detected by cystoscopy |
| Detection of a Bladder Injury by Cystoscopy | 12 months after the procedure | Number of patients with a bladder injury detected by cystoscopic examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF)- 5 | 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). |
| QMax (Peak Urinary Flow) | 1week, 3 months, 6months, 12months | Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec. |
| International Prostate Symptom Score (IPSS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety of Prostate Artery Embolization This is a study focused on the safety of prostate artery embolization based primarily on cystoscopic evaluation after embolization. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Safety of Prostate Artery Embolization |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 69.6 years |
| Baseline Cystoscopy findings | 15 Participants |
| International index of erectile function- 5 (IIEF-5) score | 12.2 units on a scale |
| International Prostate Symptom Score (IPSS) score | 23.2 units on a scale |
| Maximum urinary flow | 7.3 ml/sec |
| Prostate Size | 71.9 Grams |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 10 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Detection of a Bladder Injury
Bladder injury detected by cystoscopy
Time frame: 6 months after treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prostate Artery Embolization | Detection of a Bladder Injury | Patients evaluated | 7 Participants |
| Prostate Artery Embolization | Detection of a Bladder Injury | Number with bladder injury | 0 Participants |
Primary
Detection of a Bladder Injury by Cystoscopy
Number of patients with a bladder injury detected by cystoscopic examination
Time frame: 12 months after the procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prostate Artery Embolization | Detection of a Bladder Injury by Cystoscopy | Number with bladder injury | 0 Participants |
| Prostate Artery Embolization | Detection of a Bladder Injury by Cystoscopy | Number evaluated | 2 Participants |
Primary
Detection of Bladder Injury
Bladder injury as detected by cystoscopy
Time frame: 3 months after treatment
Population: 9 participants failed to complete this follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Artery Embolization | Detection of Bladder Injury | 0 Participants |
Primary
Number of Participants With Bladder or Rectal Injury
Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.
Time frame: Evaluated 1 week after procedure
Population: 1 patient failed to complete this follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Artery Embolization | Number of Participants With Bladder or Rectal Injury | 0 Participants |
Secondary
International Index of Erectile Function (IIEF)- 5
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).
Time frame: 1week, 3 months, 6months, 12months
Population: Some participants did not complete follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Prostate Artery Embolization | International Index of Erectile Function (IIEF)- 5 | 1 week | 17.3 score on a scale |
| Prostate Artery Embolization | International Index of Erectile Function (IIEF)- 5 | 3 months | 12.4 score on a scale |
| Prostate Artery Embolization | International Index of Erectile Function (IIEF)- 5 | 6 months | 11.9 score on a scale |
| Prostate Artery Embolization | International Index of Erectile Function (IIEF)- 5 | 12 months | 8 score on a scale |
Secondary
International Prostate Symptom Score (IPSS)
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.
Time frame: 1week, 3 months, 6months, 12months
Population: Some participants did not complete follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Prostate Artery Embolization | International Prostate Symptom Score (IPSS) | 1 week | 15.2 score on a scale |
| Prostate Artery Embolization | International Prostate Symptom Score (IPSS) | 3 months | 9.1 score on a scale |
| Prostate Artery Embolization | International Prostate Symptom Score (IPSS) | 6 months | 9.5 score on a scale |
| Prostate Artery Embolization | International Prostate Symptom Score (IPSS) | 12 months | 17.5 score on a scale |
Secondary
QMax (Peak Urinary Flow)
Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec.
Time frame: 1week, 3 months, 6months, 12months
Population: Some participants did not complete follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Prostate Artery Embolization | QMax (Peak Urinary Flow) | 1 week | 10.4 milliliters per second |
| Prostate Artery Embolization | QMax (Peak Urinary Flow) | 3 months | 18.1 milliliters per second |
| Prostate Artery Embolization | QMax (Peak Urinary Flow) | 6 months | 10.4 milliliters per second |
| Prostate Artery Embolization | QMax (Peak Urinary Flow) | 12 months | 2.2 milliliters per second |