Intermittent Catheterization Acceptance Test (I-CAT)

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.

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Self Catheterization
• Intervention / Treatment: Behavioral: Intermittent catheterization test

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Service Neuro-Urologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort; Patients with dysvoiding function and chronic urinary retention, with an indication to CISC.	Behavioral: Intermittent catheterization test; I-CAT will be a self assessment questionnaire and a simple, comprehensive and quickly passed questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermittent catheterization acceptance test (I-CAT)	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	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Gérard Amarenco, PU/PH, Assistance Publique

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): June 15, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: test; acceptance; Clean Intermittent Self Catheterization
• Other Study ID Numbers: NI11029; AOM 11014 (Other Identifier: Assistance Publique)