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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 Appleâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent self-catheterisation | Device | GentleCathâ„¢ Air intermittent catheter |
| Measure | Description | Time Frame |
|---|---|---|
| To collect physiological measurements associated with self-catheterisation using an Appleâ„¢ 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 |
| 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 GentleCathâ„¢ 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 |
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Inclusion Criteria:
• Females aged 18 years old and above who require intermittent bladder drainage
Exclusion Criteria:
• Subjects who require intermittent catheterisation to administer irrigation or instillation.
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Females (Idiopathic and Neurogenic) aged 18 years old and above who require intermittent bladder drainage
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings College Hospital | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |