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.

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Key information

Conditions

Neurogenic Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Kings College Hospital

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent self-catheterisation

Device

GentleCath™ Air intermittent catheter

Primary outcomes

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

Time frame: 28 days

Measurements of Heart Rate (variability) will be collected using the Polar H10 chest strap

Secondary outcomes

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

Time frame: 28 days

A questionnaire geared towards comfort and quality of life will be completed with self-catheterization, changes in scores will be assessed

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jan 13, 2023
Registry last updated: Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed