Intermittent Catheterization Acceptance Test

Not Applicable

Completed

• Conditions: Intermittent Self Catheterization
• Interventions: Behavioral: Intermittent catheterization test

• Registration Number: NCT01651546
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Study Start: 2013-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	Intermittent catheterization test	Patients with dysvoiding function and chronic urinary retention, with an indication to CISC.

Primary Outcome Measures

Name	Time	Method
Intermittent catheterization acceptance test (I-CAT)	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

Trial Locations

Locations (1)

Service Neuro-Urologie; 🇫🇷 Paris, France