CompletedNot Applicable

Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

United States9 participantsStarted 2017-03-01

Plain-language summary

Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia

Who can participate

Age range50 Years – 85 Years

SexMALE

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Inclusion criteria

✓. Prostate volume between 40 and 300 cm3
✓. Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
✓. Refractory or intolerant to medical management
✓. Ineligibility for or refusal of surgical management
✓. One of the following criteria:

Exclusion criteria

✕. History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer.
✕. History of rectal disease
✕. Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
✕. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing
✕. Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
✕. Cystolithiasis within the past three months
✕. Baseline serum creatinine greater than 1.8
✕. Evidence of tortuous or atherosclerotic blood vessels

What they're measuring

Number of Participants With Adverse Events

Timeframe: 12 months

Trial details

NCT IDNCT03055624

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-18

Results submitted2020-01-19

View on ClinicalTrials.gov More Prostatic Hyperplasia, Benign trials