Clinical trial NCT01651546: Intermittent Catheterization Acceptance Test
Official title: Development and Psychometric Validation of a Scale Assessing "the Acceptance" of Clean Intermittent Self Catheterization in a Neurological and no Neurological Population With Indication to Self Catheterization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Self Catheterization
Keywords: Clean Intermittent Self Catheterization
acceptance
test
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to create and validate a specific test named Intermittent Catheterization Acceptance Test (I-CAT), assessing "the acceptance" of clean intermittent self catheterization (CISC) in a neurological and no neurological population with indication to self catheterization.

CISC avoids urological complications in bladder with chronic and improves quality of life. Despite theses challenges, the learning of CISC can face some physical, cognitive and psychological difficulties. Recently, we have validate a new test for predicting the physical and cognitive abilities to practice CISC named "PP-Test". Meanwhile, psychological factors are not explored in this test. To our knowledge, no study has been conducted in order to demonstrate in a prospective trial, which kind of psychological barriers can exist. Likewise it would be interesting to create a new test assessing the psychological "acceptance" of the patients to CISC before learning (I-CAT). Based on the results of this self-assessment test, the specific nurse could then change her speech by playing down the importance of some fear and anxiety described by the patients. The learning of CISC would be facilitated.

Detailed description: The first version of the questionnaire (I-CAT) has already been elaborated from some neuro-urology experts and patients's comments.

The final version will be validated after a feasibility study. The psychometric criteria will be validated.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with neurological disease (brain, trauma and no trauma spinal injury, cauda equine syndrome) or non neurological disease
* Patients seen in consultation or in traditional hospital
* Indication for the realization of self-catheterization Intermittent must be asked because of a bladder-type retentionist or overactive bladder with an indication of medical (anticholinergics or botulinum toxin intra-detrusor injection) or surgical (kind of expansion enterocystoplasty) treatment to prevent bladder emptying without urinary catheterization
* PP-Test score ≥10/15
* Age \> 18 years
* Patient with social security

Exclusion Criteria:

* Urethral injury preventing the practice of self-catheterization
* Indication to installing a suprapubic catheter or probe
* Patients able to answer to questionnaire and communicate in French

Primary outcomes:
measure: Intermittent catheterization acceptance test (I-CAT)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service Neuro-Urologie
Study officials:
affiliation: Assistance Publique
name: Gérard Amarenco, PU/PH
role: PRINCIPAL_INVESTIGATOR
References: