Data Collection for Development of a Bladder Sensor During Urodynamics

Study Overview
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Brief Summary
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This is an explorative, single-center, feasibility study using a prototype of a future Bladder Sensor to collect data during urodynamics. Obtained data shall be used for the continuous development of the future Bladder Sensor, which is intended for use for individuals suffering from urinary incontinence.

Detailed Description
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The purpose of this clinical investigation is to collect raw measurement data of the urinary bladder region of participants (patients who are scheduled for urodynamics and fulfill the in- and exclusion criteria) with the TENA-PROTO2, for the continuous development of an algorithm to determine the bladder filling status with the future Bladder Sensor. Secondarily, safety of the subjects will be continuously 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.

Official Title
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An Explorative, Single-center, Feasibility Study to Collect Data for the Continuous Development of the Future Bladder Sensor Algorithm in Adults During Urodynamics

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: TENA-PROTO2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women Individuals at the age of ≥ 35 years Subjects who are scheduled for urodynamics BMI >18.5 kg/m² and ≤ 39.9 kg/m² Capability to understand the subject information and to provide conscious informed consent Signed informed consent for study participation and data protection regulations Willingness to conduct a urine pregnancy test for all female subjects <55 years old All female subjects <55 years old 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 Capability and willingness to follow the study protocol and procedure of the urodynamics Exclusion Criteria: Patients with breached skin, open wounds, sutures or major scar tissue in the suprapubic region Patients with suprapubic catheter Patients with urinary tract infection (UTI) Patients with implants that can be affected by electromagnetic interference (e.g. pacemaker) Patients 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 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 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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Sample size calculation: The sample size (n = 66) has been divided into three subgroups according to BMI: normal weight, overweight and obesity class I and class II. Moreover, to account for variability according to age in this sample and cover the age rage of the future intended user, subjects shall be mainly recruited in all age decades between 35-74 years.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENA-PROTO2<br>Investigational device. Late prototype | Device: TENA-PROTO2<br>* During urodynamics, the TENA-PROTO2 will be positioned onto the lower abdomen of patients to collect raw data for the continuous development of the future ultrasound bladder sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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-PROTO2) will be used to develop a product specific algorithm (R&D outcome) for the future Bladder sensor. | 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. In case on an AE, follow-up will be conducted for 14 days. | Ongoing documentation after enrolment until end of the measurement day (4 months) |