A Phase 1/2 interventional study of Prostatic Embolization with Embosphere Micropsheres in Benign Prostatic Hyperplasia, sponsored by James B. Spies, MD. Completed at 1 site in United States. Open to male participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-12-10.
Sponsored by James B. Spies, MD · Phase 1/2, Interventional, and Treatment
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.
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 15 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with James B. Spies, MD as lead sponsor.
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Exclusion Criteria:
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.
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.
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
Detection of Bladder Injury
Bladder injury as detected by cystoscopy
Time frame: 3 months after treatment
Detection of a Bladder Injury
Bladder injury detected by cystoscopy
Time frame: 6 months after treatment
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
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
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
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
| Milestone | Prostatic Embolization |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.
| Participants | Prostate Artery Embolization |
|---|---|
| Number of Participants With Bladder or Rectal Injury | 0 |
Bladder injury as detected by cystoscopy
| Participants | Prostate Artery Embolization |
|---|---|
| Detection of Bladder Injury | 0 |
Bladder injury detected by cystoscopy
| Participants | Number With Bladder Injury at 3 Months |
|---|---|
| Patients evaluated | 7 |
| Number with bladder injury | 0 |
Number of patients with a bladder injury detected by cystoscopic examination
| Participants | Cystoscopy Outcomes 12 Months |
|---|---|
| Number evaluated | 2 |
| Number with bladder injury | 0 |
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.
| score on a scale | Prostate Artery Embolization |
|---|---|
| 1 week | 15.2 (3 to 29) |
| 3 months | 9.1 (2 to 21) |
| 6 months | 9.5 (3 to 22) |
| 12 months | 17.5 (17 to 18) |
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).
| score on a scale | Prostate Artery Embolization |
|---|---|
| 1 week | 17.3 (9 to 25) |
| 3 months | 12.4 (5 to 24) |
| 6 months | 11.9 (5 to 23) |
| 12 months | 8 (7 to 9) |
Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec.
| milliliters per second | Prostate Artery Embolization |
|---|---|
| 1 week | 10.4 (0 to 21) |
| 3 months | 18.1 (6.8 to 37.8) |
| 6 months | 10.4 (2 to 12.1) |
| 12 months | 2.2 (2.2 to 2.2) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events | 0/15 (0%) | 0/15 (0%) | 10/15 (66.7%) |
| Event | Adverse Events |
|---|---|
| Dysuria or urethral painRenal and urinary disorders | 6/15 |
| HematuriaRenal and urinary disorders | 1/15 |
| acute prostatitisRenal and urinary disorders | 1/15 |
| Reported fever and chillsRenal and urinary disorders | 1/15 |
| Headache and confusionNervous system disorders | 1/15 |
| Age, Categorical(Participants) | Safety of Prostate Artery Embolization |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 11 |
| Age, Continuous(years) | Safety of Prostate Artery Embolization |
|---|---|
| Mean | 69.6 (59 to 80) |
| Sex: Female, Male(Participants) | Safety of Prostate Artery Embolization |
|---|---|
| Female | 0 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | Safety of Prostate Artery Embolization |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Safety of Prostate Artery Embolization |
|---|---|
| United States | 15 |
| Prostate Size(Grams) | Safety of Prostate Artery Embolization |
|---|---|
| Mean | 71.9 (51 to 99) |
| International Prostate Symptom Score (IPSS) score(units on a scale) | Safety of Prostate Artery Embolization |
|---|---|
| Mean | 23.2 (12 to 35) |
| International index of erectile function- 5 (IIEF-5) score(units on a scale) | Safety of Prostate Artery Embolization |
|---|---|
| Mean | 12.2 (5 to 25) |
2 further baseline measures are reported on the registry.
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