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Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Jan 1, 2026 to Jan 1, 2027v6
  2. Study description revisedv5
  3. Site details revised at 1 of 3 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 1, 2024 to Jan 1, 2026
    • Start date changed from estimate of Dec 1, 2023 to Jan 12, 2024
    • Site details revised at 3 of 3 sites
    v3
  5. Primary endpoints revised (2)
    • Secondary endpoints revised (6)
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient. This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.
Trial Details
NCT Number NCT06091566
Lead Sponsor InnoCon Medical
Collaborators: Aarhus University Hospital, Odense University Hospital, Herlev Hospital
Conditions
(from sponsor)		 Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency, Nocturia, Urinary Frequency More Than Once at Night, Bowel Disorders Functional, Incontinence, Nighttime Urinary
Related terms Fecal Incontinence, Nocturia, Nocturnal Enuresis, Urinary Incontinence, Urinary Incontinence, Urge
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov