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

NCT04720222 | Completed

• 3 other identifiers: ELECTROP2101NL76062.028.20
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  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

  4 months

Study Arms (1)

TENA-PROTO1

EXPERIMENTAL

Investigational device. Early prototype

Device: TENA-PROTO1

Interventions

TENA-PROTO1 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

TENA-PROTO1

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Novioscan - an Essity company

Nijmegen, 6534AT, Netherlands

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pieter Dik, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: April 29, 2021
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)