NCT04847609

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

April 1, 2021

Last Update Submit

October 5, 2022

Conditions

Spinal Cord InjuriesMultiple SclerosisParkinsonian DisordersAllodynia

Keywords

Neurogenic BladderIntermittent Urethral CatheterizationPainTolerance

Outcome Measures

Primary Outcomes (9)

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

    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.

    Day 1

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

    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.

    Day 3

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

    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.

    Day 7

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

    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.

    Day 14

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

    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.

    Day 21

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

    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.

    Day 28

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

    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.

    Day 35

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

    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.

    Day 45

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

    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.

    Day 90

Secondary Outcomes (26)

  • Assessment of patients' satisfaction of self-catheterisation

    Day 45

  • Assessment of patients' satisfaction of self-catheterisation

    Day 90

  • Patient compliance

    Day 45

  • Patient compliance

    Day 90

  • Measurement of the post-voiding residue on inclusion

    Day 45

  • +21 more secondary outcomes

Interventions

GentleCath™ Air catheterDEVICE

Patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord InjuriesMultiple SclerosisParkinsonian DisordersHyperalgesiaUrinary Bladder, NeurogenicPain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBasal Ganglia DiseasesBrain DiseasesMovement DisordersSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Xavier Gamé

    Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 19, 2021

Study Start

May 31, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

October 7, 2022

Record last verified: 2022-10