GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study

NCT05683938 | Completed

• 1 other identifier: CC-19-400
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neurogenic bladder; intermittent self-catherterisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  28 days

Interventions

Intermittent self-catheterisation DEVICE

GentleCath™ Air intermittent catheter

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females (Idiopathic and Neurogenic) aged 18 years old and above who require intermittent bladder drainage

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: January 13, 2023
• Study Start: November 18, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)