Data Collection for Development of a Bladder Sensor During Urodynamics

Status Recruiting

Clinical Trial Summary

This is an explorative, single-center, feasibility study using a prototype of a future Bladder Sensor to collect data during urodynamics. Obtained data shall be used for the continuous development of the future Bladder Sensor, which is intended for use for individuals suffering from urinary incontinence.

Clinical Trial Description

The purpose of this clinical investigation is to collect raw measurement data of the urinary bladder region of participants (patients who are scheduled for urodynamics and fulfill the in- and exclusion criteria) with the TENA-PROTO2, for the continuous development of an algorithm to determine the bladder filling status with the future Bladder Sensor. Secondarily, safety of the subjects will be continuously documented such as adverse events (AE) and device deficiencies (DD); AEs, Adverse Device Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device effects (SADE), Unanticipated Serious Adverse Device Effects (USADE) and DDs. ;

Study Design

Related Conditions & MeSH terms

Urinary Incontinence

Clinical Trial Details

NCT number	NCT05305846
Study type	Interventional
Source	Essity Hygiene and Health AB
Contact	Sandra Tobisch, Msc.
Phone	+4940593612299
Email	sandra.tobisch@essity.com
Status	Recruiting
Phase	N/A
Start date	March 18, 2024
Completion date	October 2024

View Details

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