Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Cap… (NCT00437528) | Clinical Trial Compass
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Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity
Israel10 participantsStarted 2006-11
Plain-language summary
A novel sensor (a device named sensurine)was developed in the aim of real- time measurement of bladder volume. The sensurine device is a wearable, fully passive, non-invasive and compact heat flow sensor (patent pending) and electronic control unit. The device will serve as a tool for managing and treating bladder dysfunction (by behavioral treatment), such as overactive bladder without incontinence, urge incontinence and voiding difficulties. In this phase I of the clinical trial the sensor unit will be tested for technological feasibility demonstration and for collecting design data.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All subjects will be aged 18-50, active, in good general health and without urinary complaints or documented urinary tract dysfunctions
Exclusion Criteria:
* Pregnancy, breast feeding, known allergic sensitivity to medical adhesive tapes, cognitive incompatibility and mental incompetence
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.