Completed

NCT Number: NCT01651546

Intermittent Catheterization Acceptance Test

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.

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Key information

Conditions

Intermittent Self Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Neuro-Urologie

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent catheterization test

Behavioral

I-CAT will be a self assessment questionnaire and a simple, comprehensive and quickly passed questionnaire.

Primary outcomes

Intermittent catheterization acceptance test (I-CAT)

Time frame: 2 years
In order to validate the questionnaire, the patients will have to respond to I-CAT at 3 times:
- the day the CISC's indication is decided
- at the learning'CISC consultation about 8 days later
- during the verification's CISC consultation about 15 days later

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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.

Acronym: I-CAT

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 27, 2012
Registry last updated: Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.