Involuntary leakage of urine Urgency
Conditions
Interventions
The SENSA bladder sensor shall be evaluated with patients, who would not have
tested this device otherwise.
Sponsors
Essity Hygiene and Health AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with urinary incontinence problems, who can feel the desire to void 2. Capability to understand the subject information and to provide conscious informed consent 3. Signed informed consent for study participation and data protection regulations 4. BMI >18.5 kg/m² and
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or breast feeding 2. Subjects with a BMI 25 kg/m² 3. Subjects who suffer from stress urinary incontinence 4. Subjects who perform clean intermittent catheterization 5. Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region. 6. Subjects with self-reported symptoms of constipation or diarrhea 7. Known allergies or intolerances to one or several components of the study product 8. Alcohol and/or drug abuse as reported by subject and/ or suspected by investigator 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 10. Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel 11. Sponsor*s or manufacturers staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint The primary endpoint is the bladder detection rate. The bladder detection rate is determined at the end of the one-week period while the subject tested the investigational device according to the intended use. It is defined as the number of times the sensor detected the bladder before urination during the one-week period (post processed sensor data) divided by the number of urinations while wearing the SENSA documented by the subject during the one-week period (subject dairy data). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint(s) 1) Actual full bladder notification rate considering all notifications of the sensor at the end of the one-week period while the subject tested the investigational device according to the intended use. The actual bladder detection rate is defined as number of notifications of SENSA of a full bladder before voiding documented by the sensor (post processed sensor data) divided by number of times the SENSA detected the bladder before urination (post processed sensor data). 2) Perceived full bladder notification rate considering all experienced notifications of the sensor by the subject at the end of the one-week period while the subject tested the investigational device according to the intended use. The perceived bladder detection rate is defined as number of experienced notifications of SENSA of a full bladder before voiding documented by the subject (subject diary) divided by number of notifications provided by the SENSA (post processed sensor data). 3) Evaluation of performance of SENSA, the connected APP, either iPhone or Apple Watch, and adhesive. 4) Evaluation of changes in voiding frequency and level of urinary incontinence among its intended user during the last week while using the SENSA Bladder Sensor, the corresponding APP and the adhesive compared to baseline (intra-individual comparison). 5) Evaluation of changes in quality of life among its adult intended user during the last week while using the SENSA Bladder Sensor, the corresponding APP and the adhesive compared to baseline (subset of the Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module; ICIQ-LUTSqol) (intra-individual comparison) 6) Evaluation of usability of SENSA Bladder Sensor, the corresponding APP and the adhesive among its adult intended user. 7) Evaluation of subject*s satisfaction of SENSA Bladder Sensor, the corresponding APP and the adhesive among its intended user. | — |
Countries
Netherlands
Outcome results
None listed