Connected Catheter (C2P) Study for Bladder Management
Connected Catheter (C2P) Study for Bladder Management
The objective of this study is to evaluate the safety and essential performance of the C2P
 System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute
 clinical setting and an extended period of home use.
Spinal Singularity had developed C2P system to address several drawbacks of current
 standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary
 prosthesis designed for improved bladder management in males with urinary retention disorders
 requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device
 that resides fully internally to the male lower urinary tract for an intended service life of
 up to 29 days per catheter
Inclusion Criteria:

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

 2. Must be clinically suitable and capable of safely managing bladder using an
 intermittent voiding or indwelling strategy

 -  Must have stable urinary management history: no significant changes in bladder
 management regimen within past 12 months

 OR:

 -  Must have urodynamic profile suitable for C2P, as assessed via urodynamics study
 within past 12 months (including bladder capacity > 200mL without uninhibited
 bladder contractions)

 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the
 C2P device, as specified in the investigational device instructions for use (IFU).

 Exclusion Criteria:

 1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may
 receive the device after Urinary Tract Infection (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 autonomic
 dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)

 4. Significant intermittent urinary incontinence (between catheterizations)

 5. Uninhibited bladder contractions and/or vesico-ureteral 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)

 7. Urinary tract inflammation or neoplasm

 8. Urinary fistula

 9. Bladder diverticulum (outpouching) > 5cm in size

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

 11. Impaired kidney function or renal failure

 12. Active gross hematuria

 13. Active urethritis

 14. Bladder stones

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

 16. Any unsuitable comorbidities as determined by the investigator or complications
 related to use of certain medications

 17. Any physical or cognitive impairments that diminish the subject's ability to follow
 directions or otherwise safely use the C2P System