Evaluation of the Safety and Clinical Performance of the 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
- 26
- Locations
- 5
- Primary Endpoint
- Successful Bladder Emptying Using Connected Catheter
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use.
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
UroDev Medical 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 4 weeks including weekly device exchange appointments. 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 \> 22 years old diagnosed with chronic Urinary Retention
- •Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling catheter strategy:
- •Must have stable urinary management history as determined by the Principal Investigator OR
- •Must have urodynamic profile suitable for the Connected Catheter (including bladder capacity ≥ 200mL without uninhibited bladder contractions)
- •Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Connected Catheter device, as specified in the Investigational Device Instructions For Use.
Exclusion Criteria
- •Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their 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
- •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 injection)
- •Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their 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
- •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 injection)
Outcomes
Primary Outcomes
Successful Bladder Emptying Using Connected Catheter
Time Frame: 4 weeks
PVR Responder Rate, defined as either: * Less than or equal to 50mL OR * Equal to or less than their baseline PVR when using SOC catheters The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.