Clinical trial · Interventional
Connected Catheter- Safety and Effectiveness Study
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurogenic Bladder | — | UNRESOLVED | — |
| Urinary Retention | — | UNRESOLVED | — |
| Urologic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Connected Urinary Catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Connected Catheter Users
- interventionNames
- Device: Connected Urinary Catheter
Primary outcomes (2)
- measure
- Successful Bladder Emptying Using Connected Catheter
- timeFrame
- 35-40 days
- description
- 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
- measure
- Rate of device related Serious Adverse Events
- timeFrame
- 0 - 40 days
- description
- Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 Must have stable urinary management history as determined by the Investigator OR: Must have urodynamic profile suitable for the 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 (UTI), as defined in this 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 (AD) 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 injections) 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 8. Bladder stones 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 Connected Catheter System 10. Catheter Assessment Tool screening yields unacceptable results
References
Publications (0)
Data not yet available