Connected Catheter- Safety and Effectiveness Study

Not Applicable

Terminated

• Conditions: Urinary Retention; Neurogenic Bladder; Urologic Diseases
• Interventions: Device: Connected Urinary Catheter

• Registration Number: NCT03843073
• Lead Sponsor: Spinal Singularity

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.

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 Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Study Start: 2020-10-16
• Primary Completion: 2021-03-23
• Study Completion: 2021-04-06
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 9

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)

3. 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)

   1. Urinary tract inflammation or neoplasm
   2. Urinary fistula
   3. Bladder diverticulum (outpouching) > 5cm in size
   4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
   5. Impaired kidney function or renal failure
   6. Active gross hematuria
   7. Active urethritis
   8. Bladder stones

7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device

8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications

9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System

10. Catheter Assessment Tool screening yields unacceptable results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Connected Catheter Users	Connected Urinary Catheter	-

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
Lower Urinary Tract injury rate	35-40 days	Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Successful sealing of the catheter valve	35-40 days	Rate of Connected Catheter valves sealed successfully
Successful device insertion, anchoring, and removal	35-40 days	Rate of Connected Catheter successfully inserted, anchored and removed
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
UTI occurrence rate	35-40 days	Rate of participants treated with the Connected Catheter reported with a urinary tract infection

Trial Locations

Locations (9)

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States

Dr. Jonathan Vapnek Urology; 🇺🇸 New York, New York, 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

Chesapeake Urology; 🇺🇸 Owings Mills, Maryland, 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, 2401 Evesham Road, Suite F; 🇺🇸 Voorhees, New Jersey, United States

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