Clinical trial NCT04095871: Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life
Official title: Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: specific time of CISC
timeFrame: 1 Day
Secondary outcomes:
measure: total time of CISC
timeFrame: 1 Day
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Neuro-Urology, Hôpital Tenon
Study officials:
References:
citation: 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.