Connected Catheter Clinical Feasibility Study( CFS)
Connected Catheter Clinical Feasibility Study( CFS)
The objective of this study is to evaluate the safety and essential performance of the
 Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD),
 both in an acute clinical setting, and during and extended period (up to 29 days) of home
 use.
The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in
 male patients 18 years of age or older who have impaired bladder emptying due to neurogenic
 lower urinary tract dysfunction, and who are capable of operating the device in accordance
 with the provided instructions for use, or who have trained caregivers capable of doing the
 same. The device must be replaced every 29 days
Inclusion Criteria:

 -  Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction
 (NLUTD)

 -  Must be clinically suitable and capable of safely managing bladder using an
 intermittent voiding strategy Must have stable urinary management history with clean
 intermittent catheterization: no significant changes in bladder management regimen
 within past 12 months

 OR:

 Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within
 past 12 months (including bladder capacity > 200mL without uninhibited bladder
 contractions)

 -  Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must
 fall within the ranges serviceable by the Connected Catheter device, as specified in
 the investigational device instructions for use.

 -  For cases of NLUTD due to spinal cord injury, the subject must be in medically stable
 condition (i.e. post-spinal shock phase)

 Exclusion Criteria:

 -  Active symptomatic urinary tract infection, as defined in this protocol (subjects may
 receive the CoCath Device after UTI has been treated)

 -  Significant risk profile or recent history of urethral stricture (e.g. stricture
 within past 90 days)

 -  Significant risk profile or recent history of clinically significant autonomic
 dysreflexia (e.g. History of hospitalization due to AD within past 12 months)

 -  Significant intermittent urinary incontinence (between catheterizations)

 -  Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably
 controlled with medication or alternate therapy (e.g. botox injections)

 -  Pre-existing urinary pathologies and/or morphological abnormalities of the lower
 urinary tract or bladder (assessed during in-depth medical screening, including
 cystoscopy, urine analysis, and blood labs)

 -  Urinary tract inflammation or neoplasm

 -  Urinary fistula

 -  Bladder diverticulum (outpouching) > 5cm in size

 -  Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6
 months)

 -  Impaired kidney function or renal failure (assessed via blood creatinine levels > 2
 mg/dL)

 -  Active gross hematuria

 -  Active urethritis

 -  Bladder stones

 -  Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted
 drug pump) or external device

 -  Individuals allergic or otherwise unable to take oral antibiotics

 -  Any physical or cognitive impairments that diminish the subject's ability to follow
 directions or otherwise safely use the CoCath System