MedTrace Logo

GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study

NCT05683938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2024-04-30

No results posted yet for this study

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

DEVICE

Intermittent self-catheterisation

GentleCath™ Air intermittent catheter

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2023-04-26
Completion
2023-04-26

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683938 on ClinicalTrials.gov