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

Withdrawn

• Conditions: Spinal Cord Injuries; Parkinsonian Disorders; Multiple Sclerosis; Allodynia

• Registration Number: NCT04847609
• Lead Sponsor: ConvaTec Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-19
• Study Start: 2021-05-31
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• Current participation in another clinical research,
• Patients not able to complete questionnaires.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of patients' satisfaction of self-catheterisation	Day 90	The pain assessment score will be based on InCaSaQ score
Patient compliance	Day 90	The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter
Measurement of the post-voiding residue on inclusion	Day 90	Post-catheterisation residue measurement (volume in mL) by ultrasound
Assessment of compliance with the self-catheterization - number of catheterizations	Day 90	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.
Assessment of compliance with the self-catheterization - Volume measurements	Day 90	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).
Description of the tolerance of the GentleCath™ Air catheter	Through study completion, approximately 13 months	The proportion and description of adverse events occurring throughout the study follow-up period will be monitored
Measurement of the overall satisfaction on Gentle Cath Air	Day 90	Patients will be questioned on the use of the catheter, service and products linked to GentleCath™ Air
Assessment of compliance with the self--catheterization - number of catheterizations	Day 3	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.
Assessment of compliance with the self-cathetization - number of catheterizations	Day 7	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.