Data Collection for Development of a Bladder Sensor During Urodynamics

Not Applicable

Recruiting

• Conditions: Urinary Incontinence
• Interventions: Device: TENA-PROTO2

• Registration Number: NCT05305846
• Lead Sponsor: Essity Hygiene and Health AB

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-31
• Status Verified: 2024-02
• Study Start: 2024-03-18
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TENA-PROTO2	TENA-PROTO2	Investigational device. Late prototype

Primary Outcome Measures

Name	Time	Method
Raw measurement data for the development of an algorithm to determine the bladder filling status	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Any adverse event (AE) or device deficiency (DD)	Ongoing documentation after enrolment until end of the measurement day (4 months)	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.

Trial Locations

Locations (1)

Canisius Wilhelmina Hospital (CWZ); 🇳🇱 Nijmegen, Netherlands