LC Bead LUMI for Prostatic Artery Embolization

Not Applicable

Completed

Conditions: BPH

Interventions: Device: Prostatic Artery Embolization

Registration Number: NCT03372096

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Prostatic Artery Embolization	Patients will receive the Prostatic Artery Embolization procedure.

Primary Outcome Measures

Name	Time	Method
Mean Change in IPSS Score	Baseline and 6 months following PAE procedure	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).

Secondary Outcome Measures

Name	Time	Method
Mean Change in Quality of Life Scores	Baseline and 6 months following PAE procedure	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.
Mean Change in Prostate Volume	Baseline and 3 months following	Change in the prostate volume measured in grams.
Mean Change in Urine Flow	Baseline and 6 months following PAE Procedure	Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second.
Mean Change in IIEF Score	Baseline and 6 months following PAE procedure	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.
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure	Up to 12 months following PAE procedure	Number of participants that experience minor complications following the PAE procedure.
Percent of Prostate Infarcted	6 months following PAE 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.
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure	3 months following 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.