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.
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.
Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.
Participant has an active infection in the genital area, including skin infections.
Participant has injured or irritated skin in the genital area, where the electrode is placed.
Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).
Parallel
Time Limited stimulation
DeviceThe 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
DeviceThe 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.
Incidence of serious adverse device effects (SADEs).
Number of SADEs.
Ratio of treatment change [performance] of OAB symptoms.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urinary Urgency (UU) voids (with or without Urgency Urinary Incontinence, UUI).
Ratio of treatment change [performance] of BD symptoms.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Faecal Urgency (FU) episodes OR at least a 50% reduction in Faecal Incontinence (FI) episodes.
Incidence and severity of adverse events (AEs).
Number of AEs.
Ratio of treatment change [performance] of Urgency Urinary Incontinence.
Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urgency Urinary Incontinence (UUI).
Self-reported quality of life measures as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) questionnaire.
The ICIQ-OABqol score of participants using UCon-Patch, compared to participants using UCon-Sham (scores can range from 0 to 100, with lower values indicating higher QoL).
Faecal Urgency (FU) episodes.
Mean reduction in number of Faecal Urgency (FU) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.
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InnoCon Medical
Lead sponsor
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Herlev Hospital
Collaborator
