Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

University of Minnesota (UMN)

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Prostate Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02930889

RAD-2016-24154

Details and patient eligibility

About

This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.

Full description

This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.

Enrollment: 21 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria:

• Male, 45 years or older
• Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months.
• IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second).
• All prostate volumes will be > 40gm
• PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination.

Exclusion criteria

• Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis.
• Cases of biopsy proven prostate, bladder, or urethral cancer.
• Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study.
• Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern.
• Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed.
• Hypersensitivity reactions to contrast material not manageable with prophylaxis.
• Patients with glomerular filtration rates less than 40 who are not already on dialysis
• Prostate volume <40 mL
• Patients with bilateral internal iliac arterial occlusion
• Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
• Patients with neurogenic or bladder atonia
• Prior prostatectomy
• Cystolithiasis within the last 3 months
• Patients interested in future fertility
• Patients with a life expectancy less than 1 year
• Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue
• Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg Parkinson's disease, multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).
• Patients with urethral stents
• Patients who have undergone prior rectal surgery other than hemorrhoidectomy or pelvic irradiation.
• Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to PAE

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Prostate Artery Embolization

Experimental group

Description:

Prostate Artery Embolization is a surgical procedure to relieve symptoms of Benign Prostatic Hyperplasia (BPH). Embolizing particles are injected into a target blood vessel to occlude blood flow.

Treatment:

Device: Prostate Artery Embolization