GentleCath Air (Urinary Self-catheterization) - Pain in Female Patients With Neurological Vesico-sphincter Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Spinal Cord Injuries, Multiple Sclerosis, Parkinsonian Disorders, Allodynia

Intervention / Treatment
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* Device: GentleCath™ Air catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Current participation in another clinical research, Patients not able to complete questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GentleCath™ Air catheter|Patients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patients' satisfaction of self-catheterisation | The pain assessment score will be based on InCaSaQ score | Day 45 | 
| Assessment of patients' satisfaction of self-catheterisation | The pain assessment score will be based on InCaSaQ score | Day 90 | 
| Patient compliance | The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter | Day 45 | 
| Patient compliance | The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter | Day 90 | 
| Measurement of the post-voiding residue on inclusion | Post-catheterisation residue measurement (volume in mL) by ultrasound | Day 45 | 
| Measurement of the post-voiding residue on inclusion | Post-catheterisation residue measurement (volume in mL) by ultrasound | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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 | 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 | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerance, Pain, Neurogenic Bladder, Intermittent Urethral Catheterization