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

Completed

• Conditions: Only healthy adult volunteers are included.; Involuntarily urine loss; 10046590

• Registration Number: NL-OMON50868
• Lead Sponsor: Essity Hygiene and Health AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1) Men, women and diverse * 35 and <75 years old
2) Capability to understand the subject information and to provide conscious
informed consent
3) Signed informed consent for study participation and data protection
regulations
4) 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
5) Willingness to conduct a urine pregnancy test for all subjects with
childbearing potential
6) BMI *18.5 kg/m² and <40 kg/m²
7) Capability and willingness to follow the following requirements: protocol,
current hygiene concept and laboratory safety

Exclusion Criteria

1) Subjects with urological problems or lower urinary tract symptoms
2) Subjects with breached skin, open wounds, sutures or major scar tissue in
the suprapubic region.
3) Subjects with active implants that can be affected by electromagnetic
interference (e.g. pacemaker)
4) Subjects with symptoms of constipation or diarrhea
5) Subjects who are pregnant or breast feeding
6) Known allergies or intolerances to one or several components of the study
product
7) 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
8) 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
9) 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*
10) Participation in any clinical investigation with systemic and/or
pharmaceutical substances within the last 4 weeks and/or in parallel*
11) Sponsors, manufacturers or CRO staff

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br><br /><br>- Bladder detectability rate as a function of gender, BMI, age, sensor<br /><br>position, posture and combinations of these variables<br /><br><br /><br>- Raw measurement data for the development of an algorithm to determine the<br /><br>bladder filling status<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br><br /><br>- Evaluation of the fixation methods and device regarding user needs by the<br /><br>subjects on a score<br /><br><br /><br>- Incidence of any adverse events (AEs) and device deficiencies; namely AEs,<br /><br>Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse<br /><br>Device Effects (SADE) and Unanticipated Serious Adverse Device Effects (USADE) </p><br>