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Data Collection for Development of a Bladder Sensor During Urodynamics

Primary Purpose

Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENA-PROTO2
Sponsored by
Essity Hygiene and Health AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Urinary Incontinence

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TENA-PROTO2

    Arm Description

    Investigational device. Late prototype

    Outcomes

    Primary Outcome Measures

    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.

    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. In case on an AE, follow-up will be conducted for 14 days.

    Full Information

    First Posted
    February 25, 2022
    Last Updated
    March 23, 2022
    Sponsor
    Essity Hygiene and Health AB
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05305846
    Brief Title
    Data Collection for Development of a Bladder Sensor During Urodynamics
    Official Title
    An Explorative, Single-center, Feasibility Study to Collect Data for the Continuous Development of the Future Bladder Sensor Algorithm in Adults During Urodynamics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    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
    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)
    Allocation
    N/A
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TENA-PROTO2
    Arm Type
    Experimental
    Arm Description
    Investigational device. Late prototype
    Intervention Type
    Device
    Intervention Name(s)
    TENA-PROTO2
    Intervention Description
    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.
    Primary Outcome Measure Information:
    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-PROTO2) will be used to develop a product specific algorithm (R&D outcome) for the future Bladder sensor.
    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. In case on an AE, follow-up will be conducted for 14 days.
    Time Frame
    Ongoing documentation after enrolment until end of the measurement day (4 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra Tobisch, Msc.
    Phone
    +4940593612299
    Email
    sandra.tobisch@essity.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul van Leuteren, PhD.
    Phone
    +31(0)621379824
    Email
    paul.vanleuteren@essity.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diederick Duijvesz, PhD.
    Organizational Affiliation
    Canisius Wilhelmina Hospital (CWZ)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Data Collection for Development of a Bladder Sensor During Urodynamics

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