Connected Catheter- Safety and Effectiveness Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Urologic Diseases; Urinary Retention; Neurogenic Bladder
• Intervention / Treatment: Device: Connected Urinary Catheter

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • 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
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology
  • 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
  • New York
    • New York, New York, United States, 10075
      • Dr. Jonathan Vapnek Urology
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

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:

1. Males age ≥ 18 with clinical diagnosis of significant urinary retention

2. 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)

3. 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:

1. Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after 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 (uncontrolled) autonomic dysreflexia (AD)
4. Significant intermittent urinary incontinence (between catheterizations)
5. Uninhibited bladder contractions and/or Vesicoureteral 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)

   1. Urinary tract inflammation or neoplasm
   2. Urinary fistula
   3. Bladder diverticulum (outpouching) > 5cm in size
   4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
   5. Impaired kidney function or renal failure
   6. Active gross hematuria
   7. Active urethritis
   8. Bladder stones
7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
10. Catheter Assessment Tool screening yields unacceptable results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Connected Catheter Users	Device: Connected Urinary Catheter; Patients will use the Connected Catheter to empty the bladder during the course of treatment.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spinal Singularity

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2020
• Primary Completion (ACTUAL): March 23, 2021
• Study Completion (ACTUAL): April 6, 2021

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Prostate cancer; Urinary Retention; Enlarged Prostate; Neurogenic Lower Urinary Tract Dysfunction (NLUTD); Catheter associated Urinary Tract Infection (CAUTI); Urinary Catheters; Spinal Cord Injury (SCI),
• Additional Relevant MeSH Terms: Nervous System Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urination Disorders; Urinary Bladder, Neurogenic; Urinary Retention; Urologic Diseases
• Other Study ID Numbers: CIP-0001 (Formerly ES-01)

Drug and device information, study documents

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