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

NCT ID: NCT04720222

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2021-10-19

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

TENA-PROTO1

Investigational device. Early prototype

Group Type: EXPERIMENTAL

TENA-PROTO1

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essity Hygiene and Health AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pieter Dik, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Novioscan - an Essity company

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

P2101

Identifier Type: OTHER

Identifier Source: secondary_id

NL76062.028.20

Identifier Type: OTHER

Identifier Source: secondary_id

ELECTRO

Identifier Type: -

Identifier Source: org_study_id