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Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life

NCT04095871 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-02-18

No results posted yet for this study

Summary

Clean Intermittent Self-Catheterization (CISC) is a procedure of regularly emptying the bladder by introducing a single-use urinary catheter through the urethra. CISC are indicated in several situations in patients with neurological pathologies but also with urological or functional disorders.

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.

Conditions

  • Intermittent Urethral Catheterization
  • Lower Urinary Tract Symptoms
  • Treatment Adherence
  • Patient Satisfaction

Interventions

OTHER

Observational study

No intervention, patients record the time of CISC

Sponsors & Collaborators

  • Gérard Amarenco

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2019-10-30
Completion
2019-10-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04095871 on ClinicalTrials.gov