Primary objectiveTo collect data for the continuous development of an algorithm to determine the bladder filling status with the future TENA Bladder Sensor.Secondary objectiveTo document adverse events (AE) and device deficiencies (DD): namely AEs,…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints
• Full bladder detection rate before urination.
Secondary outcome
Secondary endpoints
• Incidence of any AEs, DDs, ADEs, SAEs, SADEs and USADEs
Exploratory endpoints
• Minimum and maximum detectable bladder volume by TENA-PROTO2
• Relation between the bladder filling status measured by the TENA-PROTO2 and
the infused bladder volume (ml) during the urodynamics
If there is a relation between the bladder filling status determined by the
algorithm and the infused bladder volume:
(1) Full bladder detection rate (%) by future algorithm
(2) Theoretical notification rate (%), if relation is found
(3) Volume of the bladder (ml) by advanced algorithm
(4) Determine the residual urinal volume after voiding
Background summary
The future Bladder Sensor aims to prevent urinary incontinence in adult
patients (>18 years) with spinal cord injury, spina bifida, post-surgery
urinary retention, urge incontinence, overflow incontinence and who perform
intermittent catherization. In this explorative feasibility study data from
patients that match age, BMI and sex of the intended users will be collected
with the second prototype of the Bladder Sensor.
Study objective
Primary objective
To collect data for the continuous development of an algorithm to determine the
bladder filling status with the future TENA Bladder Sensor.
Secondary objective
To document adverse events (AE) and device deficiencies (DD): namely AEs, DD,
Adverse Device Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device
effects (SADE) and Unanticipated Serious Adverse Device Effects (USADE).
Exploratory objectives
According to the primary objective, data will be used for continuous
development of the algorithm in parallel to the study and beyond. First, data
will be used to determine minimum and maximum detectable bladder volume by
TENA-PROTO2 and if there is a relation between the bladder filling status
determined by the future algorithm and the infused bladder volume during
urodynamics. Second, if there is a relation between the bladder filling status
determined by the algorithm and the infused bladder volume, the following
exploratory objectives will be investigated:
(1) To determine a range in the bladder filling status which will serve as a
potential notification threshold
(2) To determine a (theoretical) notification rate and full-bladder detection
rate
(3) To determine how accurate the bladder volume can be estimated
(4) To evaluate the potential to determine residual urinal volume after voiding
Study design
This clinical investigation is designed according to the ISO 14155:2020 as
follows:
• explorative
• prospective
• mono-center
• non-randomized
• single-arm with subjects
• uncontrolled
• open-label
• interventional
• feasibility study using the TENA-PROTO2
Intervention
The second prototype of the bladder sensor shall be evaluated with patients,
who would not have tested this device otherwise.
Study burden and risks
There are no direct and primary anticipated clinical benefits of the
TENA-PROTO2 for the participating subjects even if subjects, who are scheduled
for urodynamics, would potentially benefit from the future TENA bladder sensor.
However, TENA-PROTO2 will be used during urodynamics to collect data without
any beneficial functionality for the subject at this development stage.
However, results of this explorative feasibility study will be crucial for the
sponsor to further develop the TENA Bladder Sensor, enabling users to be more
in control of their bladder, by going to the bathroom in time and remain
continent. The results will be used to, first, to determine minimum and maximum
detectable bladder volume by TENA-PROTO2 and if there is a relation between the
bladder filling status determined by the future algorithm and the infused
bladder volume during urodynamics. Second, if there is a relation between the
bladder filling status determined by the algorithm and the infused bladder
volume, the following exploratory objectives will be investigated:
(1) To determine a range in the bladder filling status which will serve as a
potential notification threshold
(2) To determine a (theoretical) notification rate and full-bladder detection
rate
(3) To determine how accurate the bladder volume can be estimated
(4) To evaluate the potential to determine residual urinal volume after voiding
Mölndals bro 2
Gothenburg SE-405 03
SE
Mölndals bro 2
Gothenburg SE-405 03
SE
Listed location countries
Age
Inclusion criteria
1. Men and women defined by biological sex at birth
2. Individuals at the age of >= 18 years
3. Subjects who are scheduled for urodynamics
4. BMI >18.5 kg/m² and <= 39.9 kg/m²
5. Capability to understand the subject information and to provide conscious
informed consent
6. Signed informed consent for study participation and data protection
regulations
7. 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.).
8. Capability and willingness to follow the study protocol and procedure of the
urodynamics
Exclusion criteria
1. Subjects with breached skin, open wounds, sutures or major scar tissue in
the suprapubic region
2. Subjects with suprapubic catheter
3. Subjects with implants that can be affected by electromagnetic interference
(e.g. pacemaker)
4. Subjects who are pregnant or breast feeding
5. Known allergies or intolerances to one or several components of the study
product
6. 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
7. 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
8. 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
9. Participation in any clinical investigation with systemic and/or
pharmaceutical substances within the last 4 weeks and/or in parallel
10. Sponsors, manufacturers or CRO staff
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05305846 |
| CCMO | NL80921.000.22 |