Connected Catheter- Safety and Effectiveness Study

The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.

Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.

Eligibility Criteria:
Inclusion Criteria:

1. Males age ≥ 18 with clinical diagnosis of significant urinary retention
2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy

   Must have stable urinary management history as determined by the Investigator

   OR:

   Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity \> 200mL without uninhibited bladder contractions)
3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for use (IFU)

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