Clinical trial NCT04847609: GentleCath Air (Urinary Self-catheterization) - Pain in Female Patients With Neurological Vesico-sphincter Disorders
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Cord Injuries
Multiple Sclerosis
Parkinsonian Disorders
Allodynia
Keywords: Neurogenic Bladder
Intermittent Urethral Catheterization
Pain
Tolerance
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
First posted: 2021-04-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 1
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 3
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 7
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 14
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 21
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 28
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 35
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 45
measure: Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway
timeFrame: Day 90
Secondary outcomes:
measure: Assessment of patients' satisfaction of self-catheterisation
timeFrame: Day 45
measure: Assessment of patients' satisfaction of self-catheterisation
timeFrame: Day 90
measure: Patient compliance
timeFrame: Day 45
measure: Patient compliance
timeFrame: Day 90
measure: Measurement of the post-voiding residue on inclusion
timeFrame: Day 45
measure: Measurement of the post-voiding residue on inclusion
timeFrame: Day 90
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 1
measure: Assessment of compliance with the self--catheterization - number of catheterizations
timeFrame: Day 3
measure: Assessment of compliance with the self-cathetization - number of catheterizations
timeFrame: Day 7
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 14
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 21
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 28
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 35
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 45
measure: Assessment of compliance with the self-catheterization - number of catheterizations
timeFrame: Day 90
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 1
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 3
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 7
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 14
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 21
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 28
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 35
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 45
measure: Assessment of compliance with the self-catheterization - Volume measurements
timeFrame: Day 90
measure: Description of the tolerance of the GentleCath™ Air catheter
timeFrame: Through study completion, approximately 13 months
measure: Measurement of the overall satisfaction on Gentle Cath Air
timeFrame: Day 90
Other outcomes:
Locations:
Study officials:
affiliation: Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil
name: Xavier Gamé
role: PRINCIPAL_INVESTIGATOR
References: