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.
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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…
Contacts

Dianna Mærsk Knudsen

40517712

dmk@innoconmedical.dk

CONTACT