inContAlert: Machine Learning Algorithms for Individual Bladder Filling Level Prediction

NCT ID: NCT05952700

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the bladder filling level of the study participants using the inContAlert sensor. The generated data will be used for the evaluation and optimization of the machine learning algorithms to be able to make precise predictions about the individual bladder fill level.

In particular, the hypothesis that the bladder filling level can be estimated by the algorithm will be tested. When testing the hypothesis, it should be determined which deviation (measured by the mean absolute percentage error) of the estimation/prediction differs from the actual value (obtained by measuring the urine output using a measuring cup in combination with kitchen scales).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Monitoring of the Bladder Filling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

inContAlert

InContAlert is a non-invasive sensor technology to measure the bladder filling level for incontinence patients. The device is fixed about 2cm above the pubic bone using a patch or strap and does not require surgery. The data collected from the patient is analyzed using deep learning algorithms. The bladder filling level determined in this way is then displayed on an app.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* informed consent

Exclusion Criteria

* Missing informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bayreuth

OTHER

Sponsor Role collaborator

inContAlert GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jannik Lockl, Dr.

Role: STUDY_DIRECTOR

inContAlert GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

inContAlert GmbH

Bayreuth, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Az. O 1305/1 -GB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.