Neurogenic BladderNCT05683938
GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
An observational study of Neurogenic Bladder, run by ConvaTec Inc. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- Intermittent self-catheterisation
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2021to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females (Idiopathic and Neurogenic) aged 18 years old and above who require intermittent bladder drainage
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Neurogenic Bladder
- Being tested
- Intermittent self-catheterisation
- Keywords
- neurogenic bladder, intermittent self-catherterisation
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent self-catheterisationDevice
GentleCath™ Air intermittent catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
A questionnaire geared towards comfort and quality of life will be completed with self-catheterization, changes in scores will be assessed
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start18 Nov 2021
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683938
- Sponsor's protocol ID
- CC-19-400
- Status last verified
- Apr 2024
- First submitted
- 22 Jul 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
- ClinicalTrials.gov ID
- NCT05683938
- Acronym / sponsor ID
- CC-19-400
- Conditions
- Neurogenic Bladder
- Keywords
- neurogenic bladder, intermittent self-catherterisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females (Idiopathic and Neurogenic) aged 18 years old and above who require intermittent bladder drainage
Key inclusion criteria (9 listed)
- • Females aged 18 years old and above who require intermittent bladder drainage
Key exclusion criteria (10 listed)
- • Subjects who require intermittent catheterisation to administer irrigation or instillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent self-catheterisationGentleCath™ Air intermittent catheter | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder, run by ConvaTec Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.