LC Bead LUMI for Prostatic Artery Embolization

Completed · Not applicable

Conditions studied: BPH

In brief

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.

Key facts

Study ID

NCT03372096

Run by

University of North Carolina, Chapel Hill

People needed

18

Starts

2018-07-13

Expected to finish

2020-09-03

Last updated by the study team

2021-02-24

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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) <12 mL/sec
• Capable of giving informed consent
• Life expectancy greater than 1 year

You may not qualify if…

• Severe vascular disease
• Uncontrolled diabetes mellitus
• Immunosuppression
• Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
• Complete urinary retention
• Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
• Confirmed or suspected bladder cancer
• Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
• Ongoing urogenital infection
• Previous pelvic radiation or radical pelvic surgery
• Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (> 10 ng/mL or > 4.0 ng/mL and < 10 ng/mL with free PSA < 25% of total PSA without a negative biopsy).
• Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
• Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Where it is running

• UNC Hospitals — Chapel Hill, North Carolina, United States
• Vascular Institute of Virginia — Woodbridge, Virginia, United States

Full record on ClinicalTrials.gov

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