N/A
N=499
Embosphere® PROstate Post Market Study
Benign Prostatic Hyperplasia · Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT03527589 ↗Enrolled (actual)
499
Serious AEs
2.1%
Results posted
Dec 2023
Primary outcome: Primary: Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS). — -11.1 scores on scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prostate artery embolization (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Merit Medical Systems, Inc.
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS). |
-11.1 | — |
| SECONDARY International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE. |
-12.4; -10.1 | — |
| SECONDARY Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index. |
-2.7; -2.4 | — |
| SECONDARY Device or Procedure Related Adverse Events Post Procedure. |
0; 0; 0 | — |
| SECONDARY Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE. |
55; 0; 0 | — |
| SECONDARY Technical Success Defined as Successful Embolization of the Treated Prostate Gland. |
432 | — |
| SECONDARY Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE). |
20; 22; 10 | — |
| SECONDARY Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM). |
-0.1 | — |
Summary
Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.
Eligibility Criteria
Inclusion Criteria
- Patient has signed informed consent
- Patient age is 18 years or older at time of informed consent
- Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
Exclusion Criteria
- Patient is unable or unwilling to provide follow-up information
- Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
- Any other reason the investigator deems cause for exclusion
Data sourced from ClinicalTrials.gov (NCT03527589). 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.