Connected Catheter (C2P) Study for Bladder Management

Not Applicable

Completed

• Conditions: Urinary Retention; Neurogenic Bladder
• Interventions: Device: C2P

• Registration Number: NCT03626324
• Lead Sponsor: Spinal Singularity

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

Study Timeline

• Study Start: 2018-07-25
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-13
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C2P Study	C2P	Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Primary Outcome Measures

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

Trial Locations

Locations (8)

Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104; 🇺🇸 Peoria, Arizona, 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

Tri Valley Urology, 25495 Medical Center Dr., Suite 204; 🇺🇸 Murrieta, California, United States

Minnesota Urology, 6025 Lake Road Suite 200; 🇺🇸 Woodbury, Minnesota, United States

New Jersey Urology, 15000 Midlantic Drive, Suite 100; 🇺🇸 Mount Laurel, New Jersey, 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