Connected Catheter (C2P) Study for Bladder Management

• Sponsor: Spinal Singularity (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03626324
• Collaborator: (none)
• Enrollment: 27
• Locations: 8
• Arm: 1
• Actual Duration (Months): 6.2
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention; Neurogenic Bladder	Device: C2P	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
• Actual Study Start Date: Jul 25, 2018
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Freedom from genito-urinary injury/trauma [3 months]

   Improved bladder management without injury to genito-urinary tract

2. Successful Acute Performance- I [Day 0 (On the day of C2P insertion)]

   To evaluate successful retention of C2P

3. Successful Acute Performance- II [Day 0 (On the day of C2P insertion)]

   To evaluate successful bladder voiding with C2P

4. Successful Acute Performance- III [Day 0 (On the day of C2P insertion)]

   To evaluate successful valve sealing of C2P

5. Successful Home-use Performance [3 months]

   To evaluate successful home use of C2P using same measures as Acute Performance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

1. 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Spinal Singularity

Investigators

• Study Director: Derek Herrera, Spinal Singularity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spinal Singularity
• ClinicalTrials.gov Identifier: NCT03626324
• Other Study ID Numbers: C2P-01
• First Posted: Aug 13, 2018
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Spinal Singularity: Spinal Cord Injury (SCI); Neurogenic Lower Urinary Tract Dysfunction (NLUTD); Catheter associated Urinary Tract Infection (CAUTI); Urinary Catheters; Dementia; Stroke; Diabetes; Parkinson's
• Additional relevant MeSH terms: Urinary Bladder, Neurogenic; Urinary Retention

Study Results

No Results Posted as of Feb 8, 2019