Urinary IncontinenceNCT04720222
Detectability of the Bladder With an Early Prototype of the Bladder Sensor
A study testing TENA-PROTO1 in people with Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in Netherlands.
Trial summary
This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence. Read more about this study
- Who is it for?
- Ages 35 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- TENA-PROTO1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Apr 2021to 19 Oct 2021
- 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 35 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men, women and diverse ≥ 35 and <75 years old
- Capability to understand the subject information and to provide conscious informed consent
- Signed informed consent for study participation and data protection regulations
- 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
- Willingness to conduct a urine pregnancy test for all subjects with childbearing potential
- BMI ≥18.5 kg/m² and <40 kg/m²
- Capability and willingness to follow the following requirements: protocol, current hygiene concept and laboratory safety
Who cannot join
- Subjects with urological problems or lower urinary tract symptoms
- Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region.
- Subjects with active implants that can be affected by electromagnetic interference (e.g. pacemaker)
- Subjects with symptoms of constipation or diarrhea
- Subjects who are pregnant or breast feeding
- Known allergies or intolerances to one or several components of the study product
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- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence.
Read the detailed description
The purpose of this clinical investigation with healthy subjects (defined as subjects without urological problems or lower urinary tract symptoms, assured by pre-defined inclusion and exclusion criteria) is to collect raw measurement data of the urinary bladder region of volunteers with the TENA-PROTO1, in multiple postural positions to evaluate the detectability of the bladder in the intended users and to determine the position criteria for the (future) ultrasound sensor on the lower abdomen. Secondarily, this clinical investigation aims to collect data on the adhesive and supportive belt used to fix the transducer assembly to the lower abdomen by the subject. Furthermore, safety of the subjects will be continously 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-PROTO1
- 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-PROTO1Device
Each volunteer will test the TENA-PROTO1 according to a standardized protocol in multiple postural positions to evaluate the detectability of the bladder by help of the investigational device
| Study group | Role | What they receive |
|---|---|---|
| TENA-PROTO1 | Experimental | Investigational device. Early prototype Receives: Device: TENA-PROTO1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder detectability rate as a function of gender, BMI, age, sensor position, posture and combinations of these variables
Percentage of those, where the bladder was detected in total or regarding different subgroups (BMI, age, sex, postural positions and sensor location ) based on raw measurement data of the urinary bladder region of volunteers with the early prototype of the Bladder Sensor in multiple postural positions to evaluate the detectability of the bladder in the intended users
Measured: 4 months
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-PROTO1) will be used to develop a product specfic algorithm (R\&D outcome)
Measured: 4 months
Secondary outcomes (2)
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.
Measured: Ongoing documentation after enrolment until end of the measurement day (4 months)
Evaluation of the fixation methods and device regarding user needs by the subjects on a score
Descriptive analyses of scores assessed by a questionnaire completed by subjects regarding the adhesive and supportive belt used to fix the transducer assembly to the lower abdomen by the subject during and at the end of the measurements
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start29 Apr 2021
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
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
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pieter Dik, Prof., Principal investigator, Department of Pediatric Urology, Wilhelmina Children's Hospital UMC Utrecht, P.O. Box 85090, 3508, AB, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720222
- Sponsor's protocol ID
- ELECTRO
- Other IDs
- P2101, NL76062.028.20
- Status last verified
- Nov 2021
- First submitted
- 20 Jan 2021
- Last updated
- 24 Nov 2021
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04720222
- Acronym / sponsor ID
- ELECTRO
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 22 Jan 2021 (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, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence.
Detailed description
The purpose of this clinical investigation with healthy subjects (defined as subjects without urological problems or lower urinary tract symptoms, assured by pre-defined inclusion and exclusion criteria) is to collect raw measurement data of the urinary bladder region of volunteers with the TENA-PROTO1, in multiple postural positions to evaluate the detectability of the bladder in the intended users and to determine the position criteria for the (future) ultrasound sensor on the lower abdomen. Secondarily, this clinical investigation aims to collect data on the adhesive and supportive belt used to fix the transducer assembly to the lower abdomen by the subject. Furthermore, safety of the subjects will be continously 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
| Arm | Type | Receives |
|---|---|---|
| TENA-PROTO1 | Experimental | Device: TENA-PROTO1Investigational device. Early prototype |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men, women and diverse ≥ 35 and <75 years old
- Capability to understand the subject information and to provide conscious informed consent
- Signed informed consent for study participation and data protection regulations
- 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
- Willingness to conduct a urine pregnancy test for all subjects with childbearing potential
Key exclusion criteria (11 listed)
- Subjects with urological problems or lower urinary tract symptoms
- Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region.
- Subjects with active implants that can be affected by electromagnetic interference (e.g. pacemaker)
- Subjects with symptoms of constipation or diarrhea
- Subjects who are pregnant or breast feeding
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-PROTO1Each volunteer will test the TENA-PROTO1 according to a standardized protocol in multiple postural positions to evaluate the detectability of the bladder by help of the investigational device | Device | TENA-PROTO1 |
Primary outcome
Bladder detectability rate as a function of gender, BMI, age, sensor position, posture and combinations of these variables
Time frame: 4 months
Percentage of those, where the bladder was detected in total or regarding different subgroups (BMI, age, sex, postural positions and sensor location ) based on raw measurement data of the urinary bladder region of volunteers with the early prototype of the Bladder Sensor in multiple postural positions to evaluate the detectability of the bladder in the intended users
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-PROTO1) will be used to develop a product specfic algorithm (R\&D outcome)
2 secondary outcomes
Any adverse event (AE) or device deficiency (DD)
Time frame: Ongoing documentation after enrolment until end of the measurement day (4 months)
Evaluation of the fixation methods and device regarding user needs by the subjects on a score
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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.
Pieter Dik, Prof. principal investigator
Department of Pediatric Urology, Wilhelmina Children's Hospital UMC Utrecht, P.O. Box 85090, 3508, AB, the Netherlands
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-PROTO1 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 24 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder detectability rate as a function of gender, BMI, age, sensor position, posture and combinations of these variables (time frame: 4 months). The study lists 2 primary outcomes in all. 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 24 Nov 2021.