Detectability of the Bladder With an Early Prototype of the Bladder Sensor

An Explorative, Monocentric, Feasibility Study to Evaluate the Detectability of the Bladder in Healthy Subjects by Ultrasound Monitoring With the Early TENA Bladder Sensor Prototype

This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: TENA-PROTO1

Detailed Description

The purpose of this clinical investigation with healthy subjects (defined as subjects without urological problems or lower urinary tract symptoms, assured by pre-defined inclusion and exclusion criteria) is to collect raw measurement data of the urinary bladder region of volunteers with the TENA-PROTO1, in multiple postural positions to evaluate the detectability of the bladder in the intended users and to determine the position criteria for the (future) ultrasound sensor on the lower abdomen. Secondarily, this clinical investigation aims to collect data on the adhesive and supportive belt used to fix the transducer assembly to the lower abdomen by the subject. Furthermore, safety of the subjects will be continously 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 (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6534AT
    • Novioscan - an Essity company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men, women and diverse ≥ 35 and <75 years old
• Capability to understand the subject information and to provide conscious informed consent
• Signed informed consent for study participation and data protection regulations
• All subjects with childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of a Pearl-Index less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices, sexual abstinence or vasectomized partner for at least 4 weeks
• Willingness to conduct a urine pregnancy test for all subjects with childbearing potential
• BMI ≥18.5 kg/m² and <40 kg/m²
• Capability and willingness to follow the following requirements: protocol, current hygiene concept and laboratory safety

Exclusion Criteria:

• Subjects with urological problems or lower urinary tract symptoms
• Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region.
• Subjects with active implants that can be affected by electromagnetic interference (e.g. pacemaker)
• Subjects with symptoms of constipation or diarrhea
• Subjects who are pregnant or breast feeding
• Known allergies or intolerances to one or several components of the study product
• 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 / study personnel
• 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 / study personnel
• 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
• Participation in any clinical investigation with systemic and/or pharmaceutical substances within the last 4 weeks and/or in parallel
• Sponsors, manufacturers or CRO staff

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TENA-PROTO1; Investigational device. Early prototype	Device: TENA-PROTO1; Each volunteer will test the TENA-PROTO1 according to a standardized protocol in multiple postural positions to evaluate the detectability of the bladder by help of the investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder detectability rate as a function of gender, BMI, age, sensor position, posture and combinations of these variables	Percentage of those, where the bladder was detected in total or regarding different subgroups (BMI, age, sex, postural positions and sensor location ) based on raw measurement data of the urinary bladder region of volunteers with the early prototype of the Bladder Sensor in multiple postural positions to evaluate the detectability of the bladder in the intended users	4 months
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-PROTO1) will be used to develop a product specfic algorithm (R&D outcome)	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.	Ongoing documentation after enrolment until end of the measurement day (4 months)
Evaluation of the fixation methods and device regarding user needs by the subjects on a score	Descriptive analyses of scores assessed by a questionnaire completed by subjects regarding the adhesive and supportive belt used to fix the transducer assembly to the lower abdomen by the subject during and at the end of the measurements	4 months

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Pieter Dik, Prof., Department of Pediatric Urology, Wilhelmina Children's Hospital UMC Utrecht, P.O. Box 85090, 3508, AB, the Netherlands

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2021
• Primary Completion (ACTUAL): October 19, 2021
• Study Completion (ACTUAL): October 19, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: ELECTRO; P2101 (METC Number); NL76062.028.20 (OTHER: Central Committee on Research Involving Human Subjects)

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