Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life
NCT ID: NCT04095871
Last Updated: 2022-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20 participants
OBSERVATIONAL
2019-07-01
2019-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The announcement of the indication of CISC is often difficult and the acceptance of this therapy remains complicated, due to the invasive side, the dependence on a material and the time required to perform CISC.
A few studies have assessed patient satisfaction and adherence to self-catheterization through quality of life questionnaires, but none have examined the impact of this technique on daily life through the duration of CISC.
Primary aim is to evaluate the impact of time to perform CISC on patient adherence and satisfaction.
Patients over 18 years old performed CISC for more than 1 month, exclusive or not, are included.
History and treatment, age, professional activity, visuals disorders, technical aids for walking and the history of CISC with the date of initiation, the type of catheter, the carrier, the number of CISC per 24 hours, the position of realization, the use of a mirror and urethral sensitivity are recorded. Cognitive disorders, fatigue, psychological state, impact on quality of life are assessed on the day of the patient's consultation. The grip of the upper limbs is explored by Box and Block and Nine Hole Peg Test. The validated questionnaires,Intermittent Catheterization Satisfaction Questionnaire ( InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) are completed.
At home, patients have to complete one calendar on the specific duration of a 24-hour self-catheterization and the next day a second calendar on the total duration of CISC
Primary outcome is specific time of self-catheterization described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
Secondary outcome is total time of self-catheterization described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity.
Influence of age, Expanded Disability Status Scale (EDSS), American Spinal Injury Association (ASIA), Montreal Cognitive Assessment (Moca), Fatigue Impact Scale (FIS), Box and Block and Nine Hole Peg Test, Hospital Anxiety and Depression Scale (HADS), Qualiveen Total,Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) on time of self-catheterization are analysis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intermittent Catheterization Acceptance Test
NCT01651546
Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention
NCT02942641
Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
NCT02616081
Filling and Emptying Cystometries ("Backwards Cystometry"): a Feasibility and Validation Study
NCT03255421
Self Management in Urinary Catheter Users
NCT00883220
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients included
Patients over 18 years old performed CISC for more than 1 month, exclusive or not, are included.
At home, patients have to complete one diary on the specific duration of a 24-hour CISC and the next day a second diary on the total duration of CISC.
The specific time of CISC described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
The total time of CISC described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity.
Observational study
No intervention, patients record the time of CISC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observational study
No intervention, patients record the time of CISC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gérard Amarenco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gérard Amarenco
Head of Neuro-Urology department, Tenon Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Neuro-Urology, Hôpital Tenon
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Leroux C, Turmel N, Chesnel C, Grasland M, Le Breton F, Amarenco G, Hentzen C. Determinants and impact of the time to perform clean intermittent self-catheterization on patient adherence and quality of life: A prospective observational study. Neurourol Urodyn. 2021 Apr;40(4):1027-1034. doi: 10.1002/nau.24662. Epub 2021 Mar 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GRC -- 01GREEN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.