Connected Catheter- Safety and Effectiveness Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

Conditions
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Urinary Retention, Neurogenic Bladder, Urologic Diseases

Intervention / Treatment
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* Device: Connected Urinary Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males age ≥ 18 with clinical diagnosis of significant urinary retention 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) 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: Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the 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 (uncontrolled) autonomic dysreflexia (AD) Significant intermittent urinary incontinence (between catheterizations) Uninhibited bladder contractions and/or Vesicoureteral 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 Connected Catheter System Catheter Assessment Tool screening yields unacceptable results

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 Users<br> | Device: Connected Urinary Catheter<br>* Patients will use the Connected Catheter to empty the bladder during the course of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Bladder Emptying Using Connected Catheter | Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter | 35-40 days | 
| Rate of device related Serious Adverse Events | Rate of participants treated with the Connected Catheter reported with a serious device related adverse event | 0 - 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful device insertion, anchoring, and removal | Rate of Connected Catheter successfully inserted, anchored and removed | 35-40 days | 
| Successful sealing of the catheter valve | Rate of Connected Catheter valves sealed successfully | 35-40 days | 
| Quality of life improvement as measured by SCI-QOL Survey and other surveys | Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys | 35-40 days | 
| UTI occurrence rate | Rate of participants treated with the Connected Catheter reported with a urinary tract infection | 35-40 days | 
| Lower Urinary Tract injury rate | Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury | 35-40 days | 

 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, Urinary Retention, Enlarged Prostate, Prostate cancer