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.

Inclusion Criteria:• Females aged 18 years old and above who require intermittent bladder drainageIdiopathic and Neurogenic subjectsBe willing and able to provide electronic informed consentBe willing and able to wear a Polar H10 chest-strapMust 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 questionsCurrently use intermittent cathetersHave used intermittent catheters for more than 6 monthsSubjects who perform intermittent catheterisation at least twice per daySpeak, read and write in EnglishExclusion Criteria:• Subjects who require intermittent catheterisation to administer irrigation or instillation.Short term voiding difficulties following Botox injectionsCurrently participating in another clinical trial or has participated in a clinical study in the previous monthCurrent users of the GentleCath™ Air intermittent catheterExhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study, for example- medical conditions that affect heart rate, anxiety disorders, uncontrolled diabetes, hyperthyroidism, psychological disorders, and other causes of blunted autonomic response.Subjects with a known alcohol dependency and/or recreational drug useCurrent symptomatic Urinary Tract Infection (UTI) or diagnosed UTI in the previous 2 weeksKnown sensitivity to the catheter device components or the Apple™ Watch or Polar™ H10 chest strapsPregnancy or breast feedingSubjects, in the opinion of the Investigator, unable to carry out the study procedures or other factors e.g. Planned surgery which may prevent them from completing the study.