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

  • STATUS
    Recruiting
  • End date
    Oct 24, 2021
  • participants needed
    100
  • sponsor
    University of Minnesota
Updated on 24 January 2021
medical therapy
prostate biopsy
digital rectal exam
digital rectal examination
benign prostatic hypertrophy
lower urinary tract symptoms
artery embolization
uroflowmetry
total psa
free psa
benign prostatic hyperplasia
hyperplasia

Summary

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

Description

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

Details
Condition Benign prostatic hypertrophy, Prostatic disorder, Prostate Disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), benign prostatic hyperplasia
Treatment Prostate Artery Embolization
Clinical Study IdentifierNCT02930889
SponsorUniversity of Minnesota
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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