Back to results

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

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

TENA-PROTO1

About this trial

This is an interventional device feasibility trial for Urinary Incontinence

Eligibility Criteria

35 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Novioscan - an Essity company

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TENA-PROTO1

Arm Description

Investigational device. Early prototype

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT04720222

First Posted

January 20, 2021

Last Updated

November 23, 2021

Sponsor

Essity Hygiene and Health AB

1. Study Identification

Unique Protocol Identification Number

NCT04720222

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 29, 2021 (Actual)

Primary Completion Date

October 19, 2021 (Actual)

Study Completion Date

October 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Essity Hygiene and Health AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TENA-PROTO1

Arm Type

Experimental

Arm Description

Investigational device. Early prototype

Intervention Type

Device

Intervention Name(s)

TENA-PROTO1

Intervention Description

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

Primary Outcome Measure Information:

Title

Bladder detectability rate as a function of gender, BMI, age, sensor position, posture and combinations of these variables

Description

Time Frame

4 months

Title

Raw measurement data for the development of an algorithm to determine the bladder filling status

Description

Raw data, that has been assessed by the prototype (TENA-PROTO1) will be used to develop a product specfic algorithm (R&D outcome)

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Any adverse event (AE) or device deficiency (DD)

Description

Documentation of AEs, Adverse Device Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device effects (SADE), Unanticipated Serious Adverse Device Effects (USADE) and DDs.

Time Frame

Ongoing documentation after enrolment until end of the measurement day (4 months)

Title

Evaluation of the fixation methods and device regarding user needs by the subjects on a score

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pieter Dik, Prof.

Organizational Affiliation

Department of Pediatric Urology, Wilhelmina Children's Hospital UMC Utrecht, P.O. Box 85090, 3508, AB, the Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novioscan - an Essity company

City

Nijmegen

ZIP/Postal Code

6534AT

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs