Data Collection for Development of a Bladder Sensor During Urodynamics

Urinary Incontinence Clinical Trial

Official title:

An Explorative, Single-center, Feasibility Study to Collect Data for the Continuous Development of the Future Bladder Sensor Algorithm in Adults During Urodynamics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305846
• Other study ID #: Neoclassic
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Essity Hygiene and Health AB
• Contact: Sandra Tobisch, Msc.
• Phone: +4940593612299
• Email: sandra.tobisch[@]essity.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects who are scheduled for urodynamics

2. Men and women defined by biological sex at birth

3. Individuals at the age of = 18 years

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 to become pregnant due to e.g., hysterectomy, postmenopausal)

8. Capability and willingness to follow the study protocol and procedure of the urodynamics

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 product

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

7. 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

8. 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

9. Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel

10. Sponsors, manufacturers or clinical research organization (CRO) staff

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• TENA-PROTO2
During urodynamics, the TENA-PROTO2 will be positioned onto the lower abdomen of patients to collect raw data for the continuous development of the future ultrasound bladder sensor.

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Hospital (CWZ)	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raw measurement data for the development of an algorithm to determine the bladder filling status	Raw data that has been assessed by the prototype (TENA-PROTO2) will be used to develop a product specific algorithm (R&D outcome) for the future Bladder sensor.	4 months
Secondary	Any adverse event (AE) or device deficiency (DD)	Documentation of AEs, Adverse Device Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device effects (SADE), Unanticipated Serious Adverse Device Effects (USADE) and DDs. In case on an AE, follow-up will be conducted for 14 days.	Ongoing documentation after enrolment until end of the measurement day (4 months)