Connected Catheter - Safety and Effectiveness Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Urologic Diseases; Urinary Retention; Neurogenic Bladder
• Intervention / Treatment: Device: Connected 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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos Rehabiliation Hospital
    • San Diego, California, United States, 92093
      • UC San Diego
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar National Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

   1. Must have stable urinary management history as determined by the investigator OR:
   2. Must have urodynamic profile suitable for 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, as defined in this clinical investigation 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
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 injection)

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
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 Gen 2 Connected Catheter System
10. Catheter Assessment Tool screening yields unacceptable results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device Related Serious Adverse Events	Rate of participants treated with the Connected Catheter reported with a serious device related adverse event	0 - 49 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With UTI (Occurrence Rate)	Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection	0 - 49 days
Number of Participants With Lower Urinary Tract Injury	Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury	0 - 40 days

Collaborators and Investigators

• Sponsor: Spinal Singularity
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Spinal Cord Injury (SCI); catheter
• Additional Relevant MeSH Terms: Nervous System Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urination Disorders; Urinary Bladder, Neurogenic; Urinary Retention; Urologic Diseases
• Other Study ID Numbers: CIP-0002 (formerly ES-NIH-01)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No