Connected Catheter- Safety and Effectiveness Study

Urinary Retention Clinical Trial

Official title:

Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03843073
• Other study ID #: CIP-0001 (Formerly ES-01)
• Status: Terminated
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: November 2021
• Source: Spinal Singularity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 6, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Retention
• Urologic Diseases

Intervention

Device:
• Connected Urinary Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.

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	Dr. Jonathan Vapnek Urology	New York	New York
United States	Chesapeake Urology	Owings Mills	Maryland
United States	Urology San Antonio	San Antonio	Texas
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	Successful Bladder Emptying Using Connected Catheter	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	35-40 days
Primary	Rate of device related Serious Adverse Events	Rate of participants treated with the Connected Catheter reported with a serious device related adverse event	0 - 40 days
Secondary	Successful device insertion, anchoring, and removal	Rate of Connected Catheter successfully inserted, anchored and removed	35-40 days
Secondary	Successful sealing of the catheter valve	Rate of Connected Catheter valves sealed successfully	35-40 days
Secondary	Quality of life improvement as measured by SCI-QOL Survey and other surveys	Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys	35-40 days
Secondary	UTI occurrence rate	Rate of participants treated with the Connected Catheter reported with a urinary tract infection	35-40 days
Secondary	Lower Urinary Tract injury rate	Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury	35-40 days