Intermittent Catheterization Acceptance Test

NCT ID: NCT01651546

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Intermittent Self Catheterization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Cohort

Patients with dysvoiding function and chronic urinary retention, with an indication to CISC.

Group Type: OTHER

Intermittent catheterization test

Intervention Type: BEHAVIORAL

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

Interventions

Intermittent catheterization test

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gérard Amarenco, PU/PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Locations

Service Neuro-Urologie

Paris, , France

Countries

France

Other Identifiers

AOM 11014

Identifier Type: OTHER

Identifier Source: secondary_id

NI11029

Identifier Type: -

Identifier Source: org_study_id