Status:
RECRUITING
Data Collection for Development of a Bladder Sensor During Urodynamics
Lead Sponsor:
Essity Hygiene and Health AB
Conditions:
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 exclusio...
Eligibility Criteria
Inclusion
- Subjects who are scheduled for urodynamics
- Men and women defined by biological sex at birth
- Individuals at the age of ≥ 18 years
- BMI \>18.5 kg/m² and ≤ 39.9 kg/m²
- Capability to understand the subject information and to provide conscious informed consent
- Signed informed consent for study participation and data protection regulations
- 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)
- Capability and willingness to follow the study protocol and procedure of the urodynamics
Exclusion
- Subjects with breached skin, open wounds, sutures or major scar tissue in the suprapubic region
- Subjects with suprapubic catheter
- Subjects with implants that can be affected by electromagnetic interference (e.g. pacemaker)
- Subjects who are pregnant or breast feeding
- Known allergies or intolerances to one or several components of the study product
- 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
- 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
- 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 clinical research organization (CRO) staff
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05305846
Start Date
March 18 2024
End Date
October 1 2024
Last Update
March 26 2024
Active Locations (1)
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1
Canisius Wilhelmina Hospital (CWZ)
Nijmegen, Netherlands, 6532SZ