An interventional, non-invasive, monocentric study to evaluate the safety and performance of the wearable ultrasound bladder sensor (SENSA) in adult patients with urinary incontinence problems
- Conditions
- 10046590Involuntary leakage of urineUrgency
- Registration Number
- NL-OMON56164
- Lead Sponsor
- Essity Hygiene and Health AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Patients with urinary incontinence problems, who can feel the desire to void
2. Capability to understand the subject information and to provide conscious
informed consent
3. Signed informed consent for study participation and data protection
regulations
4. BMI >18.5 kg/m² and <= 25 kg/m²
5. Willingness to conduct a urine pregnancy test for all female subjects <55
years old
6. Applies only for a female subject <55 years: In the Investigator*s opinion,
the subject is not likely to become pregnant during study participation (e.g.
in a same-sex relationship, not sexually active, sterile, not of child-bearing
age, uses contraception, etc.)
7. Capability and willingness to follow the study protocol
8. Patient feels comfortable with using a new APP on an iPhone or potentially
on an Apple Watch
1. Subjects who are pregnant or breast feeding
2. Subjects with a BMI <= 18.5 kg/m² or > 25 kg/m²
3. Subjects who suffer from stress urinary incontinence
4. Subjects who perform clean intermittent catheterization
5. Subjects with breached skin, open wounds, sutures or major scar tissue in
the suprapubic region.
6. Subjects with self-reported symptoms of constipation or diarrhea
7. Known allergies or intolerances to one or several components of the study
product
8. Alcohol and/or drug abuse as reported by subject and/ or suspected by
investigator
9. 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
10. Participation in any clinical investigation with systemic and/or
pharmaceutical substances within the last 4 weeks and/or in parallel
11. Sponsor*s or manufacturers staff
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>The primary endpoint is the bladder detection rate.<br /><br><br /><br>The bladder detection rate is determined at the end of the one-week period<br /><br>while the subject tested the investigational device according to the intended<br /><br>use.<br /><br><br /><br>It is defined as the number of times the sensor detected the bladder before<br /><br>urination during the one-week period (post processed sensor data) divided by<br /><br>the number of urinations while wearing the SENSA documented by the subject<br /><br>during the one-week period (subject dairy data).</p><br>
- Secondary Outcome Measures
Name Time Method