Connected Catheter (C2P) Study for Bladder Management

Urinary Retention Clinical Trial

Official title:

Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626324
• Other study ID #: C2P-01
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Spinal Singularity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Retention

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Spinal Singularity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from genito-urinary injury/trauma	Improved bladder management without injury to genito-urinary tract	3 months
Primary	Successful Acute Performance- I	To evaluate successful retention of C2P	Day 0 (On the day of C2P insertion)
Primary	Successful Acute Performance- II	To evaluate successful bladder voiding with C2P	Day 0 (On the day of C2P insertion)
Primary	Successful Acute Performance- III	To evaluate successful valve sealing of C2P	Day 0 (On the day of C2P insertion)
Primary	Successful Home-use Performance	To evaluate successful home use of C2P using same measures as Acute Performance	3 months