Connected Catheter - Safety and Effectiveness Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Post-void residual urine volume (PVR) with the use of the 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
- Successful device insertion, anchoring, and removal [35 - 40 days]
Rate of Connected Catheter successfully inserted, anchored and removed
- Successful sealing of the catheter valve [35 - 40 days]
Rate of Connected Catheter valves sealed successfully
- Quality of life improvement as measured by SCI-QOL Survey [35 - 40 days]
Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey
- UTI occurrence rate [35 - 40 days]
Rate of participants treated with the Connected Catheter reported with a urinary tract infection
- Lower Urinary Tract injury rate [35 - 40 days]
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males age ≥ 18 with clinical diagnosis of significant urinary retention
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Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
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Must have stable urinary management history as determined by the investigator OR:
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Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
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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:
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Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after UTI has been treated)
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Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
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Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia
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Significant intermittent urinary incontinence (between catheterizations)
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Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injection)
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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)
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Urinary tract inflammation or neoplasm
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Urinary fistula
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Bladder diverticulum (outpouching) > 5cm in size
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Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
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Impaired kidney function or renal failure
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Active gross hematuria
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Active urethritis
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Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
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Any unsuitable comorbidities as determined by the Investigator or complications related to use of certain medications
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Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Gen 2 Connected Catheter System
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Catheter Assessment Tool screening yields unacceptable results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rancho Los Amigos Rehabiliation Hospital | Downey | California | United States | 90242 |
| 2 | UC San Diego | San Diego | California | United States | 92093 |
| 3 | MedStar National Rehabilitation Hospital | Washington | District of Columbia | United States | 20010 |
Sponsors and Collaborators
- Spinal Singularity
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-0002 (formerly ES-NIH-01)