Connected Catheter Clinical Feasibility Study( CFS)

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 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.

Detailed Description
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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

Official Title
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Clinical Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Conditions
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Urinary Bladder, Neurogenic

Intervention / Treatment
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* Device: Connected Catheter


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 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

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: Connected Catheter Feasibility Study<br>Clinical Feasibility Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction | Device: Connected Catheter<br>* The Connected Catheter 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 CoCath 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 or trauma to genito-urinary tract | 29 Days | 
| Successful Acute Performance- I | To evaluate successful retention of Connected Catheter and Void | On the day of Connected Catheter Insertion | 
| Successful Acute Performance -II | To evaluate successful bladder voiding with Connected Catheter | On the day of Connected Catheter Insertion | 
| Successful Acute Performance- III | To evaluate successful removal of Connected Catheter | On the day of Connected Catheter Insertion | 
| Successful Acute Performance- IV | To evaluate successful post-void sealing of Connected Catheter Valve | On the day of Connected Catheter Insertion | 
| Successful Home-Use Performance | Successful Home-Use using same measures as Acute Performance | 29 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Improved Bladder Management, Neurogenic Lower Urinary Tract Dysfunction, Bladder function following Spinal Cord Injury, Urinary Retention