Collecting data for a new bladder sensor during urodynamics
An Explorative, Single-center, Feasibility Study to Collect Data for the Continuous Development of the Future Bladder Sensor Algorithm in Adults During Urodynamics
This study is testing a new bladder sensor during urodynamics to see how well it can track bladder filling and to make sure it's safe for participants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Essity Hygiene and Health AB Industry-sponsored |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT05305846 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to gather raw measurement data from the urinary bladder region of participants undergoing urodynamics using a prototype bladder sensor called TENA-PROTO2. The collected data will be utilized to develop an algorithm that determines bladder filling status, which is crucial for the future design of the bladder sensor. Additionally, the study will monitor the safety of participants by documenting any adverse events or device deficiencies throughout the process.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for urodynamics and meet specific health criteria.
Not a fit: Patients with certain medical conditions, such as those with open wounds in the suprapubic region or those who are pregnant, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a reliable bladder sensor that improves the management of urinary incontinence.
How similar studies have performed: While this approach is exploratory, similar studies in sensor technology for bladder management have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen
- Canisius Wilhelmina Hospital (CWZ) — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Diederick Duijvesz, PhD. — Canisius Wilhelmina Hospital (CWZ)
- Study coordinator: Sandra Tobisch, Msc.
- Email: sandra.tobisch@essity.com
- Phone: +4940593612299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.