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

NCT04095871 | Completed

• 1 other identifier: GRC -- 01GREEN
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intermittent urethral catheterization; Treatment adherence and compliance; Lower urinary tract symptoms; Urinary retention; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Day

Secondary Outcomes (1)

• total time of CISC

  1 Day

Study Arms (1)

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.

Other: Observational study

Interventions

Observational study OTHER

No intervention, patients record the time of CISC

Also known as: no intervention

Patients included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients \>18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.

You may qualify if:

• patients \>18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.

You may not qualify if:

• patients with an inability to comply with protocol instructions (severe cognitive disorders, language barrier, assistance with AS)

Sponsors & Collaborators

• Gérard Amarenco: lead

Study Sites (1)

Department of Neuro-Urology, Hôpital Tenon

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 33769589 DERIVED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Treatment Adherence and Compliance; Patient Satisfaction; Urinary Retention

Interventions

Observation

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Neuro-Urology department, Tenon Hospital

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: July 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)