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

Recruiting N/A Interventional Study
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
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
Female
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
InnoCon Medical · Industry
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About This Trial
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, a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participant is female 2. Participant is ≥ 18 years of age. 3. Participant is diagnosed with OAB or BD. OAB: Urinary urgency usually with one or more of the following: i. Urinary urgency incontinence (≥1 per/week). ii. Urinary frequency (≥8 voiding/day without polyuria…
Contacts

Dianna Mærsk Knudsen

40517712

dmk@innoconmedical.dk

CONTACT