An observational study in Spinal Cord Injuries, Multiple Sclerosis and Parkinsonian Disorders, sponsored by ConvaTec Inc.. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by ConvaTec Inc. · Observational
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.
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.
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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.
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Exclusion Criteria:
Patients
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 90
Assessment of patients' satisfaction of self-catheterisation
The pain assessment score will be based on InCaSaQ score
Time frame: Day 45
Assessment of patients' satisfaction of self-catheterisation
The pain assessment score will be based on InCaSaQ score
Time frame: Day 90
Patient compliance
The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter
Time frame: Day 45
Patient compliance
The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter
Time frame: Day 90
Measurement of the post-voiding residue on inclusion
Post-catheterisation residue measurement (volume in mL) by ultrasound
Time frame: Day 45
Measurement of the post-voiding residue on inclusion
Post-catheterisation residue measurement (volume in mL) by ultrasound
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Day 90
No study locations are listed for this record.
Ran from May 2021 to primary completion in Sep 2021, 3 months.
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This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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