Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Benign Prostate Hyperplasia
• Age: Between 45 Year(s) - 100 Year(s)
• Gender: Male

• Other Inclusion Criteria:
  

  1. Subject has signed an informed consent form (ICF)
  2. Men = 45 years
  3. Subjects willing to be off their BPH-related medications from time of enrollment and throughout the study
  
  Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day
  • Alpha-blockers 4 weeks prior to randomization
  • Anticholinergics 4 weeks prior to randomization
  • 5-alpha reductase inhibitors (5-ARIs)Finasteride 3 months prior to randomization
  • 5-alpha reductase inhibitors (5-ARIs)Dutasteride 6 months prior to randomization
  • Phosphodiesterase type 5 (PDE-5) inhibitors 4 weeks prior to randomization (as needed use is acceptable during study)

  
  

You may not be eligible for this study if the following are true:

• 1. Previous BPH procedure intended to disobstruct the bladder outlet (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).
  2. Biopsy of the prostate within past 8 weeks
  3. Confirmed or suspected bladder cancer
  4. History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months
  5. History of neurogenic bladder
  6. Previous episode of Acute Urinary Retention (AUR) (i.e., post hernia repair), or other condition or disease that might cause urinary retention
  7. Parkinson’s disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis)
  8. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a negative urine culture), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months)
  9. Active infection including acute bacterial prostatitis
  10. Previous pelvic irradiation or radical pelvic surgery
  11. Known allergy to nickel
  12. Subjects with life-threatening disease in which life expectancy is foreshortened are excluded
  13. Desire to maintain fertility post-treatment
  14. Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant)
  15. Any concurrent medical condition or illness that might prevent study completion or that could impact the study results such as:
  • severe cardiac arrhythmias uncontrolled by medications or pacemaker
  • congestive heart failure
  • uncontrolled diabetes mellitus
  • significant respiratory disease in which hospitalization may be required
  • known immunosuppression (i.e., AIDS, post-transplant, undergoing chemotherapy)
  16. Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure.
      Note: Low dose aspirin therapy is acceptable
  17. Unable or unwilling to complete all required questionnaires and follow-up assessments
  18. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
  19. Subject is in custody or institution