NL-OMON51822
Recruiting
Not Applicable
An explorative, single-center, feasibility study to collect data for the continuous development of the TENA Bladder Sensor Algorithm in adults during urodynamics. - Data collection for development of a bladder sensor during urodynamics.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Involuntary leakage of urine
- Sponsor
- Essity Hygiene and Health AB
- Enrollment
- 66
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men and women defined by biological sex at birth
- •2\. Individuals at the age of \>\= 18 years
- •3\. Subjects who are scheduled for urodynamics
- •4\. BMI \>18\.5 kg/m² and \<\= 39\.9 kg/m²
- •5\. Capability to understand the subject information and to provide conscious
- •informed consent
- •6\. Signed informed consent for study participation and data protection
- •regulations
- •7\. Willingness to conduct a urine pregnancy test for all female subjects \< 55
- •years old. (Exceptions: the site team determines that the subject is not likely
Exclusion Criteria
- •1\. Subjects with breached skin, open wounds, sutures or major scar tissue in
- •the suprapubic region
- •2\. Subjects with suprapubic catheter
- •3\. Subjects with implants that can be affected by electromagnetic interference
- •(e.g. pacemaker)
- •4\. Subjects who are pregnant or breast feeding
- •5\. Known allergies or intolerances to one or several components of the study
- •6\. 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
Outcomes
Primary Outcomes
Not specified
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