NCT05683938

GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neurogenic Bladder

Interventions

Type	Name	Description
DEVICE	Intermittent self-catheterisation	GentleCath™ Air intermittent catheter

Timeline

• Start date: 2021-11-18
• Primary completion: 2023-04-26
• Completion: 2023-04-26
• First posted: 2023-01-13
• Last updated: 2024-04-30

Locations

1 site across 1 country: United Kingdom