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

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ClinicalTrials.gov Identifier: NCT04847609
Recruitment Status : Not yet recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
ClinSearch
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Multiple Sclerosis Parkinsonian Disorders Allodynia Device: GentleCath™ Air catheter

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : May 31, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: GentleCath™ Air catheter
    Patients


Primary Outcome Measures :
  1. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 1 ]
    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.

  2. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 3 ]
    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.

  3. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 7 ]
    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.

  4. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 14 ]
    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.

  5. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 21 ]
    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.

  6. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 28 ]
    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.

  7. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 35 ]
    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.

  8. Pain assessment score during the insertion and removal of the GentleCath™ Air urinary catheter in female patients with confirmed neurological pathway [ Time Frame: Day 45 ]
    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.

  9. 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 Outcome Measures :
  1. Assessment of patients' satisfaction of self-catheterisation [ Time Frame: Day 45 ]
    The pain assessment score will be based on InCaSaQ score

  2. Assessment of patients' satisfaction of self-catheterisation [ Time Frame: Day 90 ]
    The pain assessment score will be based on InCaSaQ score

  3. Patient compliance [ Time Frame: Day 45 ]
    The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter

  4. Patient compliance [ Time Frame: Day 90 ]
    The proportion of patients continuing the self-catheterisation with the GentleCath™ Air catheter

  5. Measurement of the post-voiding residue on inclusion [ Time Frame: Day 45 ]
    Post-catheterisation residue measurement (volume in mL) by ultrasound

  6. Measurement of the post-voiding residue on inclusion [ Time Frame: Day 90 ]
    Post-catheterisation residue measurement (volume in mL) by ultrasound

  7. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: Day 1 ]
    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.

  8. Assessment of compliance with the self--catheterization - number of catheterizations [ Time Frame: 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.

  9. Assessment of compliance with the self-cathetization - number of catheterizations [ Time Frame: 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.

  10. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: Day 14 ]
    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.

  11. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: Day 21 ]
    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.

  12. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: Day 28 ]
    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.

  13. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: Day 35 ]
    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.

  14. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: Day 45 ]
    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.

  15. Assessment of compliance with the self-catheterization - number of catheterizations [ Time Frame: 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.

  16. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 1 ]
    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).

  17. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 3 ]
    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).

  18. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 7 ]
    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).

  19. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 14 ]
    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).

  20. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 21 ]
    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).

  21. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 28 ]
    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).

  22. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 35 ]
    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).

  23. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: Day 45 ]
    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).

  24. Assessment of compliance with the self-catheterization - Volume measurements [ Time Frame: 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).

  25. Description of the tolerance of the GentleCath™ Air catheter [ Time Frame: Through study completion, approximately 13 months ]
    The proportion and description of adverse events occurring throughout the study follow-up period will be monitored

  26. Measurement of the overall satisfaction on Gentle Cath Air [ Time Frame: Day 90 ]
    Patients will be questioned on the use of the catheter, service and products linked to GentleCath™ Air



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847609


Contacts
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Contact: Xavier Gamé +33 05 61 32 34 35 game.x@chu-toulouse.fr

Sponsors and Collaborators
ConvaTec Inc.
ClinSearch
Investigators
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Principal Investigator: Xavier Gamé Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil
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Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT04847609    
Other Study ID Numbers: CC-20-402
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ConvaTec Inc.:
Neurogenic Bladder
Intermittent Urethral Catheterization
Pain
Tolerance
Additional relevant MeSH terms:
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Multiple Sclerosis
Spinal Cord Injuries
Hyperalgesia
Parkinsonian Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Basal Ganglia Diseases
Brain Diseases
Movement Disorders