ClinicalTrials.gg
Sign In
TerminatedNCT04059159Updated Jan 20, 2023Results posted

Connected Catheter - Safety and Effectiveness Study

An interventional study of Connected Catheter in Neurogenic Bladder, Urinary Retention and Urologic Diseases, sponsored by Spinal Singularity. Terminated at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Spinal Singularity · Not applicable, Interventional, and Supportive care

Why this study was terminated
The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Neurogenic Bladder
  • Urinary Retention
  • Urologic Diseases

Keywords

  • catheter
  • Spinal Cord Injury (SCI)
03

In context

Urinary Bladder, Neurogenic

189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

This study's enrollment of 8 is below the median of 39 across 125 interventional studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

Spinal Singularity is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Device Instructions for Use (IFU).

Exclusion criteria

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 (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Connected Catheter Users

    Device: Connected Catheter

Interventions

  • DeviceConnected Catheter

    Patients will use the Connected Catheter to empty the bladder during the course of treatment.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0 - 49 days

Secondary outcomes

  1. Number of Participants With UTI (Occurrence Rate)

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

    Time frame: 0 - 49 days

  2. Number of Participants With Lower Urinary Tract Injury

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

    Time frame: 0 - 40 days

07

Results

Posted Jan 20, 2023
Limitations and caveats
single arm, small sample size

Participant flow

Participant flow — Overall Study
MilestoneConnected Catheter Users
Started8
Completed3
Not completed5

Outcome measures

PrimaryNumber of Participants With Device Related Serious Adverse Events

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

Time frame:
0 - 49 days
Reported as:
Count of participants · Participants
Number of Participants With Device Related Serious Adverse Events
ParticipantsConnected Catheter Users
Number of Participants With Device Related Serious Adverse Events0
SecondaryNumber of Participants With UTI (Occurrence Rate)

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

Time frame:
0 - 49 days
Reported as:
Count of participants · Participants
Number of Participants With UTI (Occurrence Rate)
ParticipantsConnected Catheter Users
Number of Participants With UTI (Occurrence Rate)0
SecondaryNumber of Participants With Lower Urinary Tract Injury

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

Time frame:
0 - 40 days
Reported as:
Count of participants · Participants
Number of Participants With Lower Urinary Tract Injury
ParticipantsConnected Catheter Users
Number of Participants With Lower Urinary Tract Injury0

Adverse events

Collected over From initial catheter insertion through study completion, which was up to 7 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Connected Catheter Users0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Connected Catheter Users
Mean42.4 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)Connected Catheter Users
Female0
Male8
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Connected Catheter Users
Black or African American1
White or Caucasian5
Other, Unknown or Not Reported2
Region of Enrollment
Region of Enrollment(participants)Connected Catheter Users
United States8
Weight
Weight(lbs)Connected Catheter Users
Mean166.8 ± 33.3
Ambulatory Status
Ambulatory Status(Participants)Connected Catheter Users
Fully Ambulatory3
Partially Ambulatory2
Non-Ambulatory3
08

Study locations

3 sites
  • Rancho Los Amigos Rehabiliation Hospital
    Downey, California 90242, United States
  • UC San Diego
    San Diego, California 92093, United States
  • MedStar National Rehabilitation Hospital
    Washington, District of Columbia 20010, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04059159
Lead sponsor
Spinal Singularity
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Aug 16, 2019
Start date
Oct 1, 2020
Primary completion
Mar 24, 2021
Completion
Apr 7, 2021
Results posted
Jan 20, 2023
Last update
Jan 20, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Bladder, Neurogenic →

Other studies from this sponsor

Spinal Singularity

Start the discussion