Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT04398966|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients.
Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites.
Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.
|Condition or disease||Intervention/treatment||Phase|
|BPH Enlarged Prostate (BPH) Prostatic Hyperplasia||Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia: Single Subject Study Design|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: PAE Procedure
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH)
Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres)
Other Name: HydroPearl® compressible microspheres (75 to 400 µm)
- Mean Change in IPSS at 6 Months [ Time Frame: baseline to 6 months following the procedure ]The International Prostate Symptom Score (IPSS) is an 8 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).
- Mean Change in Quality of Life Scores at 6 Months [ Time Frame: baseline to 6 months following the procedure ]The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH) from 0 to 6. Lower scores indicate a higher quality of life.
- Mean Change in Curine Flow [ Time Frame: Baseline to 6 months following the procedure ]Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)
- Mean Change in Prostate Volume [ Time Frame: baseline to 6 months following the procedure ]Change in the prostate size measured in grams (g).
- Percent of Prostate Infarcted [ Time Frame: 6 months following the procedure ]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.
- Incidence of Adverse Events [ Time Frame: up to 3 months following the procedure ]Percent of patients that experience adverse events following the PAE procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398966
|Contact: Markeela Lipscomb, BSfirstname.lastname@example.org|
|Contact: Terry Hartman, MPH,MS,CCRC|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Markeela L Lipscomb 984-974-8157 email@example.com|
|Contact: Shanah Kirk 919-966-6957 firstname.lastname@example.org|
|Sub-Investigator: Ari Isaacson, MD|
|Principal Investigator: Hyeon Yu, MD|
|Sub-Investigator: Matthew Raynor, MD|
|Principal Investigator:||Hyeon Yu, MD||University of North Carolina, Chapel Hill|