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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- ConvaTec Inc.
- Primary Endpoint
- Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Assessment of patients' satisfaction of self-catheterisation(Day 90)
- Patient compliance(Day 90)
- Measurement of the post-voiding residue on inclusion(Day 90)
- Assessment of compliance with the self-catheterization - number of catheterizations(Day 90)
- Assessment of compliance with the self-catheterization - Volume measurements(Day 90)
- Description of the tolerance of the GentleCath™ Air catheter(Through study completion, approximately 13 months)
- Measurement of the overall satisfaction on Gentle Cath Air(Day 90)
- Assessment of compliance with the self--catheterization - number of catheterizations(Day 3)
- Assessment of compliance with the self-cathetization - number of catheterizations(Day 7)