Spinal Cord InjuriesFollowAirNCT04847609
GentleCath Air (Urinary Self-catheterization) - Pain in Female Patients With Neurological Vesico-sphincter Disorders
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by ConvaTec Inc..
Trial summary
The purpose of this study is to evaluate the rate of occurrence of urethral pain in female patients with neurological vesico-sphincter disorders whilst performing self-catheterization using GentleCath™ Air catheters. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis, Parkinsonian Disorders
- What is being tested?
- GentleCath™ Air catheter
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2021to 1 Oct 2021
- 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 years and older
- Women only
- Adult, Older adult
Study population: Women under the care of the participating investigator and receiving their first prescription of GentleCath Air catheter for urinary dysfunction due to neurological disorders will be approached for potential participation in the study.
Who may be able to join
- Naive women of any self-catheterization,
- aged 18 years old or over,
- having been diagnosed with vesico-sphincteric disorders of neurological origin (spinal cord injury, multiple sclerosis, parkinsonian syndromes, ponytail syndrome),
- requiring self-catheterization and having a prescription for a GentleCath™ Air catheter.
Who cannot join
- Current participation in another clinical research,
- Patients not able to complete questionnaires.
About this study
Official title: Multicentric Observational Study of Pain When Using the GentleCath™ Air Catheter in Female Patients Followed at Home With Neurological Vesico-sphincter Disorders With Urinary Self-catheterization as a Bladder Emptying Method
The purpose of this study is to evaluate the rate of occurrence of urethral pain in female patients with neurological vesico-sphincter disorders whilst performing self-catheterization using GentleCath™ Air catheters.
Read the detailed description
Intermittent catheterisation involves the insertion and removal of a hollow flexible tube called a catheter to drain urine from the bladder. Intermittent catheterisation allows the individual to empty their bladder without the need for a long term indwelling catheter and can be implemented for people who have difficulty emptying their bladder due to neurogenic disorders.
One of the complaints of female patients performing intermittent self-catheterization for neurological bladder is the occurrence of urethral pain on insertion or removal of the catheter, in particular in patients retaining sensitivity at this level.
The GentleCath™ Air catheter was designed to improve its tolerance and in particular to reduce the risk of pain. However, no studies have addressed this in real life. Therefore, the purpose of this study is to investigate the rate of occurrence of urethral pain when using GentleCath™ Air catheters as a bladder emptying method.
In this multicentre observational study each subject will participate for 90 days. Women under the care of the participating investigator and receiving their first prescription of GentleCath Air catheter for urinary dysfunction due to neurological disorders will be approached for potential participation in the study.
The primary outcome will be the pain assessment score measured on a VAS (Visual Analog Scale) during insertion and removal of the GentleCath™ Air catheter in naive female patients with confirmed neurological pathway on D1, D3, D7, D14, D21, D28, D35, D45 and D90.
The secondary outcomes will be to assess the patients' satisfaction of self-catheterization (based on InCaSaQ score) at D45 and D90, to describe patient compliance on D45 and D90, to measure the post-voiding residue on inclusion on D45 and D90, to assess compliance with the self-catheterization throughout study duration, to describe the tolerance of the GentleCath™ Air catheter throughout study duration and to measure the overall satisfaction on Gentle Cath Air on D90.
- Being tested
- GentleCath™ Air catheter
- Keywords
- Neurogenic Bladder, Intermittent Urethral Catheterization, Pain, Tolerance
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Parkinsonian Disorders, Hyperalgesia, Urinary Bladder, Neurogenic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleCath™ Air catheterDevice
Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 1
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 3
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 7
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 14
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 21
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 28
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 35
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 45
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Measured: Day 90
Secondary outcomes (26)
Assessment of patients' satisfaction of self-catheterisation
The pain assessment score will be based on InCaSaQ score
Measured: Day 45
Assessment of patients' satisfaction of self-catheterisation
The pain assessment score will be based on InCaSaQ score
Measured: Day 90
Patient compliance
The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter
Measured: Day 45
Patient compliance
The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter
Measured: Day 90
Measurement of the post-voiding residue on inclusion
Post-catheterisation residue measurement (volume in mL) by ultrasound
Measured: Day 45
Measurement of the post-voiding residue on inclusion
Post-catheterisation residue measurement (volume in mL) by ultrasound
Measured: Day 90
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 1
Assessment of compliance with the self--catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 3
Assessment of compliance with the self-cathetization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 7
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 14
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 21
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 28
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 35
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 45
Assessment of compliance with the self-catheterization - number of catheterizations
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The number of catheterisations per 24 hours will be measured.
Measured: Day 90
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 1
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 3
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 7
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 14
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 21
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 28
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 35
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 45
Assessment of compliance with the self-catheterization - Volume measurements
Assessment will be performed through review of self-reported outcomes via a patient diary with a completed voiding calendar. The volume per catheterisation, the 24-hour diuresis, leakage of urine between catheterisation and circumstances of leakage occurrence will be measured (volume in mL).
Measured: Day 90
Description of the tolerance of the GentleCath™ Air catheter
The proportion and description of adverse events occurring throughout the study follow-up period will be monitored
Measured: Through study completion, approximately 13 months
Measurement of the overall satisfaction on Gentle Cath Air
Patients will be questioned on the use of the catheter, service and products linked to GentleCath™ Air
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start31 May 2021
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Why it stopped: Issues with patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Responsible party
- Sponsor
- Investigators
- Xavier Gamé, Principal investigator, Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847609
- Sponsor's protocol ID
- CC-20-402
- Acronym
- FollowAir
- Status last verified
- Oct 2022
- First submitted
- 1 Apr 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Study of Pain When Using the GentleCath™ Air Catheter in Female Patients Followed at Home With Neurological Vesico-sphincter Disorders With Urinary Self-catheterization as a Bladder Emptying Method
- ClinicalTrials.gov ID
- NCT04847609
- Acronym / sponsor ID
- FollowAir / CC-20-402
- Keywords
- Neurogenic Bladder, Intermittent Urethral Catheterization, Pain, Tolerance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Issues with patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Study start
- 31 May 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 19 Apr 2021 (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.
The purpose of this study is to evaluate the rate of occurrence of urethral pain in female patients with neurological vesico-sphincter disorders whilst performing self-catheterization using GentleCath™ Air catheters.
Detailed description
Intermittent catheterisation involves the insertion and removal of a hollow flexible tube called a catheter to drain urine from the bladder. Intermittent catheterisation allows the individual to empty their bladder without the need for a long term indwelling catheter and can be implemented for people who have difficulty emptying their bladder due to neurogenic disorders.
One of the complaints of female patients performing intermittent self-catheterization for neurological bladder is the occurrence of urethral pain on insertion or removal of the catheter, in particular in patients retaining sensitivity at this level.
The GentleCath™ Air catheter was designed to improve its tolerance and in particular to reduce the risk of pain. However, no studies have addressed this in real life. Therefore, the purpose of this study is to investigate the rate of occurrence of urethral pain when using GentleCath™ Air catheters as a bladder emptying method.
In this multicentre observational study each subject will participate for 90 days. Women under the care of the participating investigator and receiving their first prescription of GentleCath Air catheter for urinary dysfunction due to neurological disorders will be approached for potential participation in the study.
The primary outcome will be the pain assessment score measured on a VAS (Visual Analog Scale) during insertion and removal of the GentleCath™ Air catheter in naive female patients with confirmed neurological pathway on D1, D3, D7, D14, D21, D28, D35, D45 and D90.
The secondary outcomes will be to assess the patients' satisfaction of self-catheterization (based on InCaSaQ score) at D45 and D90, to describe patient compliance on D45 and D90, to measure the post-voiding residue on inclusion on D45 and D90, to assess compliance with the self-catheterization throughout study duration, to describe the tolerance of the GentleCath™ Air catheter throughout study duration and to measure the overall satisfaction on Gentle Cath Air on D90.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women under the care of the participating investigator and receiving their first prescription of GentleCath Air catheter for urinary dysfunction due to neurological disorders will be approached for potential participation in the study.
Key inclusion criteria (4 listed)
- Naive women of any self-catheterization,
- aged 18 years old or over,
- having been diagnosed with vesico-sphincteric disorders of neurological origin (spinal cord injury, multiple sclerosis, parkinsonian syndromes, ponytail syndrome),
- requiring self-catheterization and having a prescription for a GentleCath™ Air catheter.
Key exclusion criteria (2 listed)
- Current participation in another clinical research,
- Patients not able to complete questionnaires.
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 |
|---|---|---|
| GentleCath™ Air catheterPatients | Device | – |
Primary outcome
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 1
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 3
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 7
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 14
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 21
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 28
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 35
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 45
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Time frame: Day 90
The pain assessment score will be measured on a VAS (Visual Analog Scale). The scale has a minimum value of 0 and a maximum value of 10. A higher score indicates a worse outcome indicating greater levels of pain and discomfort.
26 secondary outcomes
Assessment of patients' satisfaction of self-catheterisation
Time frame: Day 45
Assessment of patients' satisfaction of self-catheterisation
Time frame: Day 90
Patient compliance
Time frame: Day 45
Patient compliance
Time frame: Day 90
Measurement of the post-voiding residue on inclusion
Time frame: Day 45
Measurement of the post-voiding residue on inclusion
Time frame: Day 90
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 1
Assessment of compliance with the self--catheterization - number of catheterizations
Time frame: Day 3
Assessment of compliance with the self-cathetization - number of catheterizations
Time frame: Day 7
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 14
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 21
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 28
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 35
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 45
Assessment of compliance with the self-catheterization - number of catheterizations
Time frame: Day 90
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 1
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 3
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 7
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 14
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 21
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 28
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 35
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 45
Assessment of compliance with the self-catheterization - Volume measurements
Time frame: Day 90
Description of the tolerance of the GentleCath™ Air catheter
Time frame: Through study completion, approximately 13 months
Measurement of the overall satisfaction on Gentle Cath Air
Time frame: Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
Xavier Gamé principal investigator
Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by ConvaTec Inc..
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway (time frame: Day 1). The study lists 9 primary outcomes in all. 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 7 Oct 2022.