Connected Catheter Clinical Feasibility Study( CFS)

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Neurogenic
• Intervention / Treatment: Device: Connected Catheter

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90241
      • West Coast Urology, 11411 Brookshire Avenue, Suite 508
    • Murrieta, California, United States, 92562
      • Tri Valley Urology, 25495 Medical Center Dr., Suite 204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Connected Catheter Feasibility Study; Clinical Feasibility Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Device: Connected Catheter; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spinal Singularity

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Urinary Retention; Improved Bladder Management; Neurogenic Lower Urinary Tract Dysfunction; Bladder function following Spinal Cord Injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic
• Other Study ID Numbers: CoCath-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No