Connected Catheter- Safety and Effectiveness Study

Exclusion Criteria

• •1. Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after UTI has been treated)
• •2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
• •3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia (AD)
• •4. Significant intermittent urinary incontinence (between catheterizations)
• •5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
• •6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)
• •1. Urinary tract inflammation or neoplasm
• •2. Urinary fistula
• •3. Bladder diverticulum (outpouching) \> 5cm in size
• •4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
• •5. Impaired kidney function or renal failure
• •6. Active gross hematuria
• •7. Active urethritis
• •8. Bladder stones
• •7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
• •8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
• •9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
• •10. Catheter Assessment Tool screening yields unacceptable results