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UCon Treatment of Overactive Bladder (OAB) in Males

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 1, 2025 (before its estimated June 12, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Jun 12, 2025 to Jun 12, 2026v5
  2. Notable Primary and study completion dates: Oct 12, 2024 to Jun 12, 2025v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 1, 2024 to Oct 12, 2024
    • Start date changed from estimate of Sep 1, 2023 to Oct 12, 2023
    • Site details revised
    v3
  4. Notable Start date: Jun 1, 2023 to Sep 1, 2023
    • Primary and study completion dates: Jun 1, 2024 to Sep 1, 2024
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
Trial Details
NCT Number NCT05874375
Lead Sponsor InnoCon Medical
Conditions
(from sponsor)
Urinary Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night, Urinary Incontinence, Urge, Incontinence, Nighttime Urinary
Related terms Nocturia, Nocturnal Enuresis, Urinary Incontinence, Urinary Incontinence, Urge
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov