An explorative, single-center, feasibility study to collect data for the continuous development of the TENA Bladder Sensor Algorithm in adults during urodynamics.
- Conditions
- Involuntary leakage of urineUrgency10046590
- Registration Number
- NL-OMON51822
- Lead Sponsor
- Essity Hygiene and Health AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 66
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints<br /><br>• Full bladder detection rate before urination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br>• Incidence of any AEs, DDs, ADEs, SAEs, SADEs and USADEs<br /><br><br /><br>Exploratory endpoints<br /><br>• Minimum and maximum detectable bladder volume by TENA-PROTO2<br /><br>• Relation between the bladder filling status measured by the TENA-PROTO2 and<br /><br>the infused bladder volume (ml) during the urodynamics<br /><br><br /><br>If there is a relation between the bladder filling status determined by the<br /><br>algorithm and the infused bladder volume:<br /><br>(1) Full bladder detection rate (%) by future algorithm<br /><br>(2) Theoretical notification rate (%), if relation is found<br /><br>(3) Volume of the bladder (ml) by advanced algorithm<br /><br>(4) Determine the residual urinal volume after voiding</p><br>