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.
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…
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