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Intermittent Catheterization Acceptance Test (I-CAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01651546
First received: July 25, 2012
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Intermittent Self Catheterization
Behavioral: Intermittent catheterization test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Intermittent catheterization acceptance test (I-CAT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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


Enrollment: 200
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651546

Locations
France
Service Neuro-Urologie
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Gérard Amarenco, PU/PH Assistance Publique
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01651546     History of Changes
Other Study ID Numbers: NI11029  AOM 11014 
Study First Received: July 25, 2012
Last Updated: June 12, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Clean Intermittent Self Catheterization
acceptance
test

ClinicalTrials.gov processed this record on September 23, 2016