Clinical trial NCT02930889: Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Official title: Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Therapeutic Embolization
Prostatic Artery Embolization
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 21
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse Events Reported
timeFrame: 3 Months
measure: Change in International Prostate Symptom Score
timeFrame: baseline, 3 months
measure: Change in Quality of Life Scale (QOLS)
timeFrame: 3 months
measure: Patient Reported Change in Medication Use
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jafar Golzarian, MD
role: PRINCIPAL_INVESTIGATOR
References: