Neurogenic Bladder, Urinary Retention, Urologic Diseases
Conditions
Keywords
catheter, Spinal Cord Injury (SCI)
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.
Interventions
DEVICEConnected Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Spinal Singularity
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Related Serious Adverse Events | 0 - 49 days | Rate of participants treated with the Connected Catheter reported with a serious device related adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With UTI (Occurrence Rate) | 0 - 49 days | Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection |
| Number of Participants With Lower Urinary Tract Injury | 0 - 40 days | Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Connected Catheter Users Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Connected Catheter Users |
|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 10 |
| Ambulatory Status Fully Ambulatory | 3 Participants |
| Ambulatory Status Non-Ambulatory | 3 Participants |
| Ambulatory Status Partially Ambulatory | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Other, Unknown or Not Reported | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 5 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight | 166.8 lbs STANDARD_DEVIATION 33.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
Population: This is based on the number of patients who had catheter insertion attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Connected Catheter Users | Number of Participants With Device Related Serious Adverse Events | 0 Participants |
Secondary
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
Population: This is based on the number of patients who had catheter insertion attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Connected Catheter Users | Number of Participants With Lower Urinary Tract Injury | 0 Participants |
Secondary
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
Population: This is based on the number of patients who had catheter insertion attempted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Connected Catheter Users | Number of Participants With UTI (Occurrence Rate) | 0 Participants |