N/A
N=18
LC Bead LUMI for Prostatic Artery Embolization
BPH
Bottom Line
View on ClinicalTrials.gov: NCT03372096 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Mean Change in IPSS Score — -11.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prostatic Artery Embolization (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in IPSS Score |
-11.4 | — |
| SECONDARY Mean Change in Quality of Life Scores |
-2 | — |
| SECONDARY Mean Change in Urine Flow |
3.3 | — |
| SECONDARY Mean Change in Prostate Volume |
-20 | — |
| SECONDARY Percent of Prostate Infarcted |
— | — |
| SECONDARY Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure |
8 | — |
| SECONDARY Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure |
8 | — |
| SECONDARY Mean Change in IIEF Score |
-1.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male
- Age > 40
- Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)
- Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
- Moderate to severe LUTS as defined by IPSS score >18
- Peak urine flow rate (Qmax) 1.8 mg/dL or a glomerular filtration rate 10 ng/mL or > 4.0 ng/mL and 1.5 or platelets < 50,000
- Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Data sourced from ClinicalTrials.gov (NCT03372096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.