Connected Catheter (C2P) Study for Bladder Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Conditions
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Urinary Retention, Neurogenic Bladder

Intervention / Treatment
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* Device: C2P


Participation Criteria
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Eligibility Criteria
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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 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) 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: Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (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 (AD) (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 and urine analysis) 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 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 Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P System

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C2P Study<br>Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction | Device: C2P<br>* The C2P is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The C2P is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from genito-urinary injury/trauma | Improved bladder management without injury to genito-urinary tract | 3 months | 
| Successful Acute Performance- I | To evaluate successful retention of C2P | Day 0 (On the day of C2P insertion) | 
| Successful Acute Performance- II | To evaluate successful bladder voiding with C2P | Day 0 (On the day of C2P insertion) | 
| Successful Acute Performance- III | To evaluate successful valve sealing of C2P | Day 0 (On the day of C2P insertion) | 
| Successful Home-use Performance | To evaluate successful home use of C2P using same measures as Acute Performance | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury (SCI), Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Dementia, Stroke, Diabetes, Parkinson's