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.
The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks. The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms. For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation. To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
The 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.
The 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.
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGHerlev Hospital
Herlev, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGIncidence of serious adverse device effects (SADEs).
Number of SADEs.
Time frame: At 12 weeks.
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).
Time frame: Change from baseline at 6 weeks.
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.
Time frame: Change from baseline at 6 weeks.
Incidence and severity of adverse events (AEs).
Number of AEs.
Time frame: At 12 weeks.
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).
Time frame: Change from baseline at 6 weeks.
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).
Time frame: Change from baseline at 6 weeks.
Faecal Urgency (FU) episodes.
Mean reduction in number of Faecal Urgency (FU) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.
Time frame: Change from baseline at 6 weeks.
Faecal Incontinence (FI) episodes.
Mean reduction in number of Faecal Incontinence (FI) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.
Time frame: Change from baseline at 6 weeks.
Self-reported quality of life measures as assessed by the Rockwood Fecal Incontinence Quality of Life Scale (FIQL) questionnaire.
The FIQL score of participants using UCon-Patch, compared to participants using UCon-Sham (the scale consists of 4 scales, with each scale ranging from 1-5, with 1 indicating a lower functional QoL).
Time frame: Change from baseline at 6 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.