Data Collection for Development of a Bladder Sensor During Urodynamics

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: TENA-PROTO2

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 Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Tobisch, Msc.; Phone Number: +4940593612299; Email: sandra.tobisch@essity.com
• Study Contact Backup: Name: Paul van Leuteren, PhD.; Phone Number: +31(0)621379824; Email: paul.vanleuteren@essity.com

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6532SZ
    • Recruiting
    • Canisius Wilhelmina Hospital (CWZ)
    • Contact: Diederick Duijvesz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENA-PROTO2; Investigational device. Late prototype	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Diederick Duijvesz, PhD., Canisius Wilhelmina Hospital (CWZ)

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence
• Other Study ID Numbers: Neoclassic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No