Fecal Incontinence, Fecal Incontinence With Fecal Urgency, Incontinence, Nighttime Urinary, Nocturia, Urinary, Urinary Frequency More Than Once at Night, Urinary Incontinence, Urinary Incontinence, Urge
Conditions
Keywords
Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve
Brief summary
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.
Detailed description
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.
Interventions
DEVICETime Limited stimulation
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.
DEVICESham stimulation
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.
Sponsors
Aarhus University Hospital
Odense University Hospital
Herlev Hospital
InnoCon Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants are assigned to a treatment group and a sham group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
* 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). * Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function). * Participant is pregnant, nursing, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception\* during the clinical investigation. * Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment. * Participant has previously participated in a clinical investigation with UCon. * Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years. * Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome. * Participant has a history of cancer in the pelvic region, is currently receiving cancer treatment, or has received radiation therapy in the pelvic region. * Participant had surgery in the pelvic region within the previous 6 months. If it can be excluded that the participant's symptoms are related to the surgery, they can be included in the clinical investigation. * Participant has addictive behavior defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs. * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse device effects (SADEs). | At 12 weeks. | Number of SADEs. |
| Ratio of treatment change [performance] of OAB symptoms. | Change from baseline at 6 weeks. | 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. | Change from baseline at 6 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Faecal Urgency (FU) episodes. | Change from baseline at 6 weeks. | Mean reduction in number of Faecal Urgency (FU) episodes of participants using UCon-Patch, compared to participants using UCon-Sham. |
| Incidence and severity of adverse events (AEs). | At 12 weeks. | Number of AEs. |
| Self-reported quality of life measures as assessed by the Rockwood Fecal Incontinence Quality of Life Scale (FIQL) questionnaire. | Change from baseline at 6 weeks. | 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). |
| Faecal Incontinence (FI) episodes. | Change from baseline at 6 weeks. | Mean reduction in number of Faecal Incontinence (FI) episodes of participants using UCon-Patch, compared to participants using UCon-Sham. |
| Ratio of treatment change [performance] of Urgency Urinary Incontinence. | Change from baseline at 6 weeks. | 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. | Change from baseline at 6 weeks. | 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). |
Countries
Denmark
Contacts
Primary ContactDianna Mærsk Knudsen
Outcome results
None listed