Only healthy adult volunteers are included. Involuntarily urine loss
Conditions
Interventions
The early prototype of the Bladder Sensor will be tested by healthy volunteers,
who would not test this device otherwise.
Sponsors
Essity Hygiene and Health AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Men, women and diverse * 35 and
Exclusion criteria
Exclusion criteria: 1) Subjects with urological problems or lower urinary tract symptoms 2) Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region. 3) Subjects with active implants that can be affected by electromagnetic interference (e.g. pacemaker) 4) Subjects with symptoms of constipation or diarrhea 5) Subjects who are pregnant or breast feeding 6) Known allergies or intolerances to one or several components of the study product 7) Alcohol abuse as*reported*by subject and/ or suspected by investigator that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator / study personnel 8) Drug abuse*as reported by subject and/ or suspected by investigator*that impacts capability to understand the subject information and to provide conscious informed consent in the discretion of the investigator / study personnel 9) Objections of the investigator to the subject*s participation in the trial due to medical reasons or any other reason for which the subject should not participate in the opinion of the investigator* 10) Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel* 11) Sponsors, manufacturers or CRO staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: - Bladder detectability rate as a function of gender, BMI, age, sensor position, posture and combinations of these variables - Raw measurement data for the development of an algorithm to determine the bladder filling status | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Evaluation of the fixation methods and device regarding user needs by the subjects on a score - Incidence of any adverse events (AEs) and device deficiencies; namely AEs, Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE) and Unanticipated Serious Adverse Device Effects (USADE) | — |
Countries
Netherlands
Outcome results
None listed