Intermittent Catheterization Acceptance Test (I-CAT)

• ClinicalTrials.gov Identifier: NCT01651546
• Recruitment Status: Completed
• First Posted: July 27, 2012
• Last Update Posted: June 15, 2015
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intermittent Self Catheterization	Behavioral: Intermittent catheterization test	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: March 2013
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: NI11029; AOM 11014 ( Other Identifier: Assistance Publique )
• First Posted: July 27, 2012
• Last Update Posted: June 15, 2015
• Last Verified: June 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Clean Intermittent Self Catheterization; acceptance; test