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Prostatic artery embolization (PAE) for treatment of benign prostatic hyperplasia (BPH)

Sponsored by Northwestern University

Phase Quota
Phase N/A

This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).

Study Start Date: January 2014

Estimated Completion Date: January 2020

Specialties: Urology: Oncology,Prostate Oncology: Renal/Urologic

Interventions

  • Device: Prostate Artery Embolization

Inclusion criteria

  • Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment
  • Ability to understand and the willingness to sign a written informed consent
  • Prostate volumes 40 - 90 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months
  • Men ≥ 45 years of age
  • IPSS symptom score > 13 and IPSS bother score > 2
  • Peak flow rate Qmax  12 with voided volume ≥ 125 cc

Exclusion criteria

  • History of prostate or bladder cancer, pelvic radiation, untreated bladder stones
  • On alpha-blockers within the past 2 weeks. Unless part of a trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR)
  • On 5-alpha reductase inhibitors within the past 6 months
  • On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks
  • On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication and willingness to stay on the same dose for the duration of the study
  • Daily use of a pad or device for incontinence required
  • Urethral strictures, renal insufficiency (i.e. creatinine > 1.8)
  • Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function
  • Neurogenic bladder, Hypotonic Bladder
  • Prior treatment for urinary incontinence
  • Penile prosthesis
  • Artificial urinary sphincter
  • Documented bacterial prostatitis within the past year
  • Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization
  • History of chronic prostatitis within the last 1 year
  • Known bleeding disorders (e.g. von willebrand disease (VWD))
  • History of urethral strictures/bladder neck closure (BNC)
  • Prior prostate procedures (e.g. Transurethral microwave therapy (TUMT), transurethral needle ablation of the prostate (TUNA), water-induced thermotherapy (WIT), transurethral resection of the prostate (TURP), photo-vaporization of the prostate (PVP))
  • Prior treatment for overactive bladder (e.g. intravesical botox)
  • Prostate Specific Antigen (PSA) > 4.0, < 10.0 unless documented negative prostate biopsy within past 2 years and is not thought to harbor prostatic malignancy in the clinical opinion of the primary or co-investigator
  • Enrolled in another treatment trial for any disease within the past 30 days
  • Declines or unable to provide informed consent
  • Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
  • Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression

Study Locations And Contact Information

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