GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
As part of the ongoing Clinical Evaluation and Post Market Clinical Follow Up (PMCF) activities it was determined that a pilot study should be conducted to look at how real life data such as various physiological measurements can be collected via a Smart-Watch during intermittent self-catheterisation whilst also collecting real life feedback from users on comfort as measured by levels of possible discomfort and on levels of anxiety which may be associated with intermittent catheterisation over a period of time. Adherence to catheter regimen and proper emptying of the bladder is of clinical relevance for clean intermittent catheterisation. A Daily Fluid Diary is included in this pilot study together with the use of the microphone of the Apple™ Smart Watch to investigate the feasibility of tracking input and output of fluids. The user acceptance of the Daily Fluid Diary offered via the iPhone app and the feasibility of the microphone to capture bladder emptying or voiding are to be tested within this pilot.
• • Females aged 18 years old and above who require intermittent bladder drainage
‣ Idiopathic and Neurogenic subjects
⁃ Be willing and able to provide electronic informed consent
⁃ Be willing and able to wear a Polar H10 chest-strap
⁃ Must be willing and able to use the smart technology provided e.g. Smart Phone with software application and/or smart watch to answer the required questions
⁃ Currently use intermittent catheters
⁃ Have used intermittent catheters for more than 6 months
⁃ Subjects who perform intermittent catheterisation at least twice per day
⁃ Speak, read and write in English