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Connected Catheter- Safety and Effectiveness Study

Primary Purpose

Urinary Retention, Neurogenic Bladder, Urologic Diseases

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connected Urinary Catheter
Sponsored by
Spinal Singularity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Retention focused on measuring Spinal Cord Injury (SCI),, Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Urinary Retention, Enlarged Prostate, Prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • West Coast Urology, 11411 Brookshire Avenue, Suite 508
  • West Coast Urology, 575 E. Hardy St., Suite 215
  • Tri Valley Urology, 25495 Medical Center Dr., Suite 204
  • Chesapeake Urology
  • Minnesota Urology, 6025 Lake Road Suite 200
  • New Jersey Urology, 15000 Midlantic Drive, Suite 100
  • New Jersey Urology, 2401 Evesham Road, Suite F
  • Dr. Jonathan Vapnek Urology
  • Urology San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Connected Catheter Users

Arm Description

Outcomes

Primary Outcome Measures

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
Rate of device related Serious Adverse Events
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event

Secondary Outcome Measures

Successful device insertion, anchoring, and removal
Rate of Connected Catheter successfully inserted, anchored and removed
Successful sealing of the catheter valve
Rate of Connected Catheter valves sealed successfully
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
UTI occurrence rate
Rate of participants treated with the Connected Catheter reported with a urinary tract infection
Lower Urinary Tract injury rate
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury

Full Information

First Posted
February 7, 2019
Last Updated
November 15, 2021
Sponsor
Spinal Singularity
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1. Study Identification

Unique Protocol Identification Number
NCT03843073
Brief Title
Connected Catheter- Safety and Effectiveness Study
Official Title
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spinal Singularity

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Neurogenic Bladder, Urologic Diseases
Keywords
Spinal Cord Injury (SCI),, Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Urinary Retention, Enlarged Prostate, Prostate cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Connected Catheter Users
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Connected Urinary Catheter
Intervention Description
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Primary Outcome Measure Information:
Title
Successful Bladder Emptying Using Connected Catheter
Description
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
Time Frame
35-40 days
Title
Rate of device related Serious Adverse Events
Description
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Time Frame
0 - 40 days
Secondary Outcome Measure Information:
Title
Successful device insertion, anchoring, and removal
Description
Rate of Connected Catheter successfully inserted, anchored and removed
Time Frame
35-40 days
Title
Successful sealing of the catheter valve
Description
Rate of Connected Catheter valves sealed successfully
Time Frame
35-40 days
Title
Quality of life improvement as measured by SCI-QOL Survey and other surveys
Description
Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys
Time Frame
35-40 days
Title
UTI occurrence rate
Description
Rate of participants treated with the Connected Catheter reported with a urinary tract infection
Time Frame
35-40 days
Title
Lower Urinary Tract injury rate
Description
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Time Frame
35-40 days

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
West Coast Urology, 11411 Brookshire Avenue, Suite 508
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
West Coast Urology, 575 E. Hardy St., Suite 215
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Minnesota Urology, 6025 Lake Road Suite 200
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
New Jersey Urology, 15000 Midlantic Drive, Suite 100
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
New Jersey Urology, 2401 Evesham Road, Suite F
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Dr. Jonathan Vapnek Urology
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Connected Catheter- Safety and Effectiveness Study

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