An interventional study of Prostatic Artery Embolization in BPH, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.
Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
Exclusion Criteria
Patients will receive the Prostatic Artery Embolization procedure.
Device: Prostatic Artery Embolization
LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.
Also known as: LC Bead LUMI
Mean Change in IPSS Score
The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
Time frame: Baseline and 6 months following PAE procedure
Mean Change in Quality of Life Scores
The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5.
Time frame: Baseline and 6 months following PAE procedure
Mean Change in Urine Flow
Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second.
Time frame: Baseline and 6 months following PAE Procedure
Mean Change in Prostate Volume
Change in the prostate volume measured in grams.
Time frame: Baseline and 3 months following
Percent of Prostate Infarcted
Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.
Time frame: 6 months following PAE procedure
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure
Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation.
Time frame: 3 months following PAE procedure
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure
Number of participants that experience minor complications following the PAE procedure.
Time frame: Up to 12 months following PAE procedure
Mean Change in IIEF Score
Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function.
Time frame: Baseline and 6 months following PAE procedure
| Milestone | All Patients |
|---|---|
| Started | 18 |
| Received intervention | 10 |
| Completed | 10 |
| Not completed | 8 |
| Withdrew: Study closed | 8 |
The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
| units on a scale | Patients With 6 Month Follow up |
|---|---|
| Mean Change in IPSS Score | -11.4 ± 8.4 |
The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5.
| units on a scale | Patients With 6 Month Follow up Data |
|---|---|
| Mean Change in Quality of Life Scores | -2 ± 1.3 |
Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second.
| mL/s | All Patients With 6 Month Uroflow Testing |
|---|---|
| Mean Change in Urine Flow | 3.3 ± 4.5 |
Change in the prostate volume measured in grams.
| grams | All Patients |
|---|---|
| Mean Change in Prostate Volume | -20 ± 23.2 |
Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.
No measurements were reported for this outcome.
Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation.
| Participants | All Patients |
|---|---|
| Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure | 8 |
Number of participants that experience minor complications following the PAE procedure.
| Participants | All Patients |
|---|---|
| Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure | 8 |
Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function.
| units on a scale | All Patients |
|---|---|
| Mean Change in IIEF Score | -1.1 ± 13.4 |
Collected over 1 year following PAE procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Event | All Patients |
|---|---|
| brief penile pain and sensitivityRenal and urinary disorders | 3/10 |
| brief rectalgia or anal painRenal and urinary disorders | 2/10 |
| dysuriaRenal and urinary disorders | 2/10 |
| temporary increased urgency to urinateRenal and urinary disorders | 2/10 |
| increased frequencyRenal and urinary disorders | 1/10 |
| penile ulcerationRenal and urinary disorders | 1/10 |
| temporary hematuriaRenal and urinary disorders | 1/10 |
| temporary urinary retentionRenal and urinary disorders | 1/10 |
| Age, Continuous(years) | All Patients |
|---|---|
| Mean | 70 ± 6 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 0 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | All Patients |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Patients |
|---|---|
| United States | 18 |
| IPSS(units on a scale) | All Patients |
|---|---|
| Mean | 22.5 ± 4.2 |
| IIEF(units on a scale) | All Patients |
|---|---|
| Mean | 46 ± 22 |
| Quality of Life(units on a scale) | All Patients |
|---|---|
| Mean | 4.5 ± 0.7 |
1 further baseline measures are reported on the registry.
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University of North Carolina, Chapel Hill