LC Bead LUMI for Prostatic Artery Embolization

University of North Carolina (UNC)

Status: Completed

Conditions: BPH

Treatments: Device: Prostatic Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03372096

17-2782

Details and patient eligibility

About

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.

Full 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

Enrollment: 18 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male
2. Age > 40
3. Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)
4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
5. Moderate to severe LUTS as defined by IPSS score >18
6. Peak urine flow rate (Qmax) <12 mL/sec
7. Capable of giving informed consent
8. Life expectancy greater than 1 year

Exclusion Criteria

1. Severe vascular disease
2. Uncontrolled diabetes mellitus
3. Immunosuppression
4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
5. Complete urinary retention
6. 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.
7. Confirmed or suspected bladder cancer
8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
9. Ongoing urogenital infection
10. Previous pelvic radiation or radical pelvic surgery
11. 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).
12. Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

All patients

Experimental group

Description:

Patients will receive the Prostatic Artery Embolization procedure.

Treatment:

Device: Prostatic Artery Embolization