Connected Catheter (C2P) Study for Bladder Management
Primary Purpose
Urinary Retention, Neurogenic Bladder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C2P
Sponsored by
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, Dementia, Stroke, Diabetes, Parkinson's
Eligibility Criteria
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 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)
- 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:
- Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (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 (AD) (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 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 C2P System
Sites / Locations
- Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
- Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
- 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
- Minnesota Urology, 6025 Lake Road Suite 200
- New Jersey Urology, 15000 Midlantic Drive, Suite 100
- New Jersey Urology, 2401 Evesham Road, Suite F
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C2P Study
Arm Description
Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Outcomes
Primary Outcome Measures
Freedom from genito-urinary injury/trauma
Improved bladder management without injury to genito-urinary tract
Successful Acute Performance- I
To evaluate successful retention of C2P
Successful Acute Performance- II
To evaluate successful bladder voiding with C2P
Successful Acute Performance- III
To evaluate successful valve sealing of C2P
Successful Home-use Performance
To evaluate successful home use of C2P using same measures as Acute Performance
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03626324
Brief Title
Connected Catheter (C2P) Study for Bladder Management
Official Title
Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Neurogenic Bladder
Keywords
Spinal Cord Injury (SCI), Neurogenic Lower Urinary Tract Dysfunction (NLUTD), Catheter associated Urinary Tract Infection (CAUTI), Urinary Catheters, Dementia, Stroke, Diabetes, Parkinson's
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
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C2P Study
Arm Type
Experimental
Arm Description
Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Intervention Type
Device
Intervention Name(s)
C2P
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freedom from genito-urinary injury/trauma
Description
Improved bladder management without injury to genito-urinary tract
Time Frame
3 months
Title
Successful Acute Performance- I
Description
To evaluate successful retention of C2P
Time Frame
Day 0 (On the day of C2P insertion)
Title
Successful Acute Performance- II
Description
To evaluate successful bladder voiding with C2P
Time Frame
Day 0 (On the day of C2P insertion)
Title
Successful Acute Performance- III
Description
To evaluate successful valve sealing of C2P
Time Frame
Day 0 (On the day of C2P insertion)
Title
Successful Home-use Performance
Description
To evaluate successful home use of C2P using same measures as Acute Performance
Time Frame
3 months
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 neurogenic lower urinary tract dysfunction (NLUTD)
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)
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:
Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (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 (AD) (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 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 C2P System
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Herrera
Organizational Affiliation
Spinal Singularity
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
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
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
12. IPD Sharing Statement
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Connected Catheter (C2P) Study for Bladder Management
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