Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urinary Retention
- Sponsor
- Spinal Singularity
- Enrollment
- 9
- Locations
- 9
- Primary Endpoint
- Successful Bladder Emptying Using Connected Catheter
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males age ≥ 18 with clinical diagnosis of significant urinary retention
- •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
- •Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity \> 200mL without uninhibited bladder contractions)
- •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
- •Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after UTI has been treated)
- •Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
- •Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia (AD)
- •Significant intermittent urinary incontinence (between catheterizations)
- •Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
- •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)
- •Urinary tract inflammation or neoplasm
- •Urinary fistula
- •Bladder diverticulum (outpouching) \> 5cm in size
- •Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
Outcomes
Primary Outcomes
Successful Bladder Emptying Using Connected Catheter
Time Frame: 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
Time Frame: 0 - 40 days
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Secondary Outcomes
- Lower Urinary Tract injury rate(35-40 days)
- Successful sealing of the catheter valve(35-40 days)
- Successful device insertion, anchoring, and removal(35-40 days)
- Quality of life improvement as measured by SCI-QOL Survey and other surveys(35-40 days)
- UTI occurrence rate(35-40 days)