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Safety and Performance of UCon Patch Electrode

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jan 15, 2028 to Mar 20, 2028
    • Start date changed from estimate of Feb 15, 2025 to Mar 20, 2025
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 15, 2025 to Feb 15, 2025
    • Site details revised at 3 of 3 sites
    v3
  3. Secondary endpoints: details revised at 2 of 6 entriesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient. This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.
Trial Details
NCT Number NCT06754189
Lead Sponsor InnoCon Medical
Collaborators: Aarhus University Hospital, Odense University Hospital, Herlev Hospital
Conditions
(from sponsor)		 Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night, Urinary, Incontinence, Nighttime Urinary, Fecal Incontinence, Fecal Incontinence With Fecal Urgency
Related terms Fecal Incontinence, Nocturia, Nocturnal Enuresis, Urinary Incontinence, Urinary Incontinence, Urge
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov