Data Collection for Development of a Bladder Sensor During Urodynamics

NCT05305846 | Recruiting

• 1 other identifier: Neoclassic
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Ongoing documentation after enrolment until end of the measurement day (4 months)

Study Arms (1)

TENA-PROTO2

EXPERIMENTAL

Investigational device. Late prototype

Device: TENA-PROTO2

Interventions

TENA-PROTO2 DEVICE

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.

TENA-PROTO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are scheduled for urodynamics
• Men and women defined by biological sex at birth
• Individuals at the age of ≥ 18 years
• 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 (Exceptions: the site team determines that the subject is not likely to become pregnant due to e.g., hysterectomy, postmenopausal)
• Capability and willingness to follow the study protocol and procedure of the urodynamics

You may not qualify if:

• Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region
• Subjects with suprapubic catheter
• Subjects with implants that can be affected by electromagnetic interference (e.g. pacemaker)
• 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
• 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 clinical research organization (CRO) staff

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Canisius Wilhelmina Hospital (CWZ)

Nijmegen, 6532SZ, Netherlands

RECRUITING

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

• Diederick Duijvesz, PhD.

  Canisius Wilhelmina Hospital (CWZ)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Tobisch, Msc.

CONTACT

+4940593612299; sandra.tobisch@essity.com

Paul van Leuteren, PhD.

CONTACT

+31(0)621379824; paul.vanleuteren@essity.com

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

Model Details: 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; minimum 6 subjects each group. Dropouts will be replaced.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 31, 2022
• Study Start: March 18, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)