Urinary IncontinenceNCT05305846
Data Collection for Development of a Bladder Sensor During Urodynamics
A study testing TENA-PROTO2 in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- TENA-PROTO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Mar 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Canisius Wilhelmina Hospital (CWZ)
Nijmegen, 6532SZ
Diederick Duijvesz, MD
About this study
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
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- TENA-PROTO2
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENA-PROTO2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| TENA-PROTO2 | Experimental | Investigational device. Late prototype Receives: Device: TENA-PROTO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: Ongoing documentation after enrolment until end of the measurement day (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start18 Mar 2024
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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; minimum 6 subjects each group. Dropouts will be replaced.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diederick Duijvesz, PhD., Principal investigator, Canisius Wilhelmina Hospital (CWZ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305846
- Sponsor's protocol ID
- Neoclassic
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05305846
- Acronym / sponsor ID
- Neoclassic
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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; minimum 6 subjects each group. Dropouts will be replaced.
| Arm | Type | Receives |
|---|---|---|
| TENA-PROTO2 | Experimental | Device: TENA-PROTO2Investigational device. Late prototype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENA-PROTO2During 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. | Device | TENA-PROTO2 |
Primary outcome
Raw measurement data for the development of an algorithm to determine the bladder filling status
Time frame: 4 months
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.
1 secondary outcome
Any adverse event (AE) or device deficiency (DD)
Time frame: Ongoing documentation after enrolment until end of the measurement day (4 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederick Duijvesz, PhD. principal investigator
Canisius Wilhelmina Hospital (CWZ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENA-PROTO2 in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Tobisch, Msc. (+4940593612299, sandra.tobisch@essity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raw measurement data for the development of an algorithm to determine the bladder filling status (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.