Safety and Performance of UCon Patch Electrode

Sponsor
InnoCon Medical
Study ID
NCT06754189
Status
Recruiting
Apply to this trial

Conditions

  • Fecal Incontinence
  • Fecal Incontinence With Fecal Urgency
  • Incontinence, Nighttime Urinary
  • Nocturia
  • Urinary
  • Urinary Frequency More Than Once at Night
  • Urinary Incontinence
  • Urinary Incontinence, Urge

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Time Limited stimulation — DEVICE
    The participant self-administer 30 min. of electrical stimulation using Time Limited stimulation to the dorsal genital nerve (DGN) for 6 weeks using UCon with the UCon-Patch electrode.
  • Sham stimulation — DEVICE
    The participant self-administer 30 min. of sham stimulation to the dorsal genital nerve (DGN) for 6 weeks using a sham device with the UCon-Patch electrode.

Study Details

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.

Key Dates

First listed
Dec 31, 2024
Start date
Mar 20, 2025
Status verified
Mar 2025
Primary completion
Mar 20, 2028
Completion
Mar 20, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Electrical stimulation (Time Limited stimulation) to the dorsal genital nerve.
  • Sham Comparator: Sham group
    Sham stimulation to the dorsal genital nerve.

Primary Outcome Measure

Incidence of serious adverse device effects (SADEs). [ Time Frame: At 12 weeks. ]

Central Contacts

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