Connected Catheter- Safety and Effectiveness Study

• Sponsor: Spinal Singularity (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03843073
• Collaborator: (none)
• Enrollment: 9
• Locations: 9
• Arm: 1
• Actual Duration (Months): 5.7
• Patient Per Site: 1
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention; Neurogenic Bladder; Urologic Diseases	Device: Connected Urinary Catheter	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
• Actual Study Start Date: Oct 16, 2020
• Actual Primary Completion Date: Mar 23, 2021
• Actual Study Completion Date: Apr 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Connected Catheter Users	Device: Connected Urinary Catheter; Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Outcome Measures

Primary Outcome Measures

1. Successful Bladder Emptying Using Connected Catheter [35-40 days]

   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

2. Rate of device related Serious Adverse Events [0 - 40 days]

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

Secondary Outcome Measures

1. Successful device insertion, anchoring, and removal [35-40 days]

   Rate of Connected Catheter successfully inserted, anchored and removed

2. Successful sealing of the catheter valve [35-40 days]

   Rate of Connected Catheter valves sealed successfully

3. Quality of life improvement as measured by SCI-QOL Survey and other surveys [35-40 days]

   Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys

4. UTI occurrence rate [35-40 days]

   Rate of participants treated with the Connected Catheter reported with a urinary tract infection

5. Lower Urinary Tract injury rate [35-40 days]

   Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury

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 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)

1. 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)

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 Connected Catheter System

18. Catheter Assessment Tool screening yields unacceptable results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Urology, 11411 Brookshire Avenue, Suite 508	Downey	California	United States	90241
2	West Coast Urology, 575 E. Hardy St., Suite 215	Inglewood	California	United States	90301
3	Tri Valley Urology, 25495 Medical Center Dr., Suite 204	Murrieta	California	United States	92562
4	Chesapeake Urology	Owings Mills	Maryland	United States	21117
5	Minnesota Urology, 6025 Lake Road Suite 200	Woodbury	Minnesota	United States	55125
6	New Jersey Urology, 15000 Midlantic Drive, Suite 100	Mount Laurel	New Jersey	United States	08054
7	New Jersey Urology, 2401 Evesham Road, Suite F	Voorhees	New Jersey	United States	08043
8	Dr. Jonathan Vapnek Urology	New York	New York	United States	10075
9	Urology San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Spinal Singularity

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spinal Singularity
• ClinicalTrials.gov Identifier: NCT03843073
• Other Study ID Numbers: CIP-0001 (Formerly ES-01)
• First Posted: Feb 15, 2019
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Spinal Singularity: Spinal Cord Injury (SCI),; Neurogenic Lower Urinary Tract Dysfunction (NLUTD); Catheter associated Urinary Tract Infection (CAUTI); Urinary Catheters; Urinary Retention; Enlarged Prostate; Prostate cancer
• Additional relevant MeSH terms: Urinary Bladder, Neurogenic; Urinary Retention; Urologic Diseases

Study Results

No Results Posted as of Nov 23, 2021