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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENA-PROTO2 | Experimental | Investigational device. Late prototype |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Ongoing documentation after enrolment until end of the measurement day (4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Tobisch, Msc. | Contact | +4940593612299 | sandra.tobisch@essity.com | |
| Paul van Leuteren, PhD. | Contact | +31(0)621379824 | paul.vanleuteren@essity.com |
| Name | Affiliation | Role |
|---|---|---|
| Diederick Duijvesz, PhD. | Canisius Wilhelmina Hospital (CWZ) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius Wilhelmina Hospital (CWZ) | Recruiting | Nijmegen | 6532SZ | Netherlands |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |