Connected Catheter (C2P) Study for Bladder Management

Clinical Evaluation of Connected Catheter 2P (C2P) 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 C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.

Study Overview

• Status: Completed
• Conditions: Urinary Retention; Neurogenic Bladder
• Intervention / Treatment: Device: C2P

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Peoria, Arizona, United States, 85351
      • Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
    • Surprise, Arizona, United States, 85374
      • Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
  • California
    • Downey, California, United States, 90241
      • West Coast Urology, 11411 Brookshire Avenue, Suite 508
    • Inglewood, California, United States, 90301
      • West Coast Urology, 575 E. Hardy St., Suite 215
    • Murrieta, California, United States, 92562
      • Tri Valley Urology, 25495 Medical Center Dr., Suite 204
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Urology, 6025 Lake Road Suite 200
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • New Jersey Urology, 15000 Midlantic Drive, Suite 100
    • Voorhees, New Jersey, United States, 08043
      • New Jersey Urology, 2401 Evesham Road, Suite F

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)

2. 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)
3. 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:

1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (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 autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)
4. Significant intermittent urinary incontinence (between catheterizations)
5. Uninhibited bladder contractions and/or vesico-ureteral 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)
7. Urinary tract inflammation or neoplasm
8. Urinary fistula
9. Bladder diverticulum (outpouching) > 5cm in size
10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
11. Impaired kidney function or renal failure
12. Active gross hematuria
13. Active urethritis
14. Bladder stones
15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P 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: C2P Study; Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Device: C2P; 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.

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 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

Collaborators and Investigators

• Sponsor: Spinal Singularity
• Investigators: Study Director: Derek Herrera, Spinal Singularity

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes; Stroke; Dementia; Spinal Cord Injury (SCI); Parkinson's; Neurogenic Lower Urinary Tract Dysfunction (NLUTD); Catheter associated Urinary Tract Infection (CAUTI); Urinary Catheters
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urination Disorders; Urinary Bladder, Neurogenic; Urinary Retention
• Other Study ID Numbers: C2P-01

Drug and device information, study documents

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