Data Collection for Development of a Bladder Sensor During Urodynamics

Launched by ESSITY HYGIENE AND HEALTH AB · Mar 23, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called a Bladder Sensor that could help people with urinary incontinence. The study will collect data from participants during a specific test called urodynamics, which helps measure how well the bladder functions. This information will be used to improve the Bladder Sensor for future use in patients who experience bladder control issues.

To participate, you need to be at least 18 years old, scheduled for urodynamics, and meet certain health criteria, such as having a body mass index (BMI) within a specific range. You also need to be able to understand the study information and provide consent to participate. If you join the study, you can expect to undergo the urodynamics test while the researchers collect data to help develop the Bladder Sensor. It's important to note that some people may not be eligible due to certain health conditions, pregnancy, or other factors. This study is currently recruiting participants, so if you think you might be interested, please reach out for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who are scheduled for urodynamics
• • 2. Men and women defined by biological sex at birth
• • 3. Individuals at the age of ≥ 18 years
• • 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 clinical research organization (CRO) staff