Safety and Performance of UCon Patch Electrode
Recruiting
N/A
Interventional Study
Urinary Incontinence
Urinary Incontinence, Urge
Nocturia
Urinary Frequency More Than Once at Night
Urinary
Incontinence, Nighttime Urinary
Fecal Incontinence
Fecal Incontinence With Fecal Urgency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 180 (estimated)
- Sponsor
- InnoCon Medical · Industry
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About This Trial
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-blin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant is ≥ 18 years of age.
* Participant is diagnosed with OAB or BD.
* Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.
Ex…
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