GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study

Conditions
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Neurogenic Bladder

Intervention / Treatment
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* Device: Intermittent self-catheterisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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 Exclusion Criteria: • Subjects who require intermittent catheterisation to administer irrigation or instillation. Short term voiding difficulties following Botox injections Currently participating in another clinical trial or has participated in a clinical study in the previous month Current users of the GentleCath™ Air intermittent catheter Exhibiting 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 use Current symptomatic Urinary Tract Infection (UTI) or diagnosed UTI in the previous 2 weeks Known sensitivity to the catheter device components or the Apple™ Watch or Polar™ H10 chest straps Pregnancy or breast feeding Subjects, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intermittent self-catheterisation|GentleCath™ Air intermittent catheter|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect physiological measurements associated with self-catheterisation using an Apple™ Watch 6.0, an iPhone SE 2020 and a Polar H10 chest-strap plus a software application | Measurements of Heart Rate (variability) will be collected using the Polar H10 chest strap | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain user feedback, in a Real-Life setting, on the comfort as measured by the level of discomfort in the use of GentleCath™ Air intermittent catheter and related QoL and anxiety associated with self-catheterisation in general | A questionnaire geared towards comfort and quality of life will be completed with self-catheterization, changes in scores will be assessed | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurogenic bladder, intermittent self-catherterisation