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

• ClinicalTrials.gov Identifier: NCT04847609
• Recruitment Status: Withdrawn
• First Posted: April 19, 2021
• Last Update Posted: October 7, 2022
• Sponsor: ConvaTec Inc.
• Collaborator: ClinSearch
• Information provided by (Responsible Party): ConvaTec Inc.

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 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
• Actual Study Start Date: May 31, 2021
• Actual Primary Completion Date: September 1, 2021
• Actual Study Completion Date: October 1, 2021

Groups and Cohorts

Intervention Details:

• Device: GentleCath™ Air catheter
  Patients

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

ConvaTec Inc.

ClinSearch

Investigators

• Principal Investigator: Xavier Gamé; Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil

More Information

• Responsible Party: ConvaTec Inc.
• ClinicalTrials.gov Identifier: NCT04847609
• Other Study ID Numbers: CC-20-402
• First Posted: April 19, 2021
• Last Update Posted: October 7, 2022
• Last Verified: October 2022

• 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:

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