Overactive Bladder Clinical Trial
Official title:
Phase I Study for Evaluating the Safety and Applicability of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Healthcare Campus | Haifa | Northern region |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
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