Impact Evaluation of Different Micturition Modes on Patients With Medullar Injury of Quality of Life and Their Occupations

Completed

• Conditions: Medullary Injury; Micturition Disorder

• Registration Number: NCT05475093
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-22
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Adult patients with spinal cord injury;

• Live at home or in long-term care facility definitively;

• Have one of the following urination modes:

  1. urine with indwelling catheter in place
  2. catheter in suprapubic area
  3. intermittent catheterization by urethra
  4. intermittent catheterization by incontinent cystostomy
  5. sphincterotomy
  6. incontinent stomia (Bricker)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life by QUALIVEEN-30	at baseline	The questionnaire QUALIVEEN-30 will be used to evaluate the quality of life. It's a reliable tool specially for patients with medullar injury and recommended by the European Association of Urology as Guideline since 2008. The french version is validated.
Model of human occupation	at baseline	Questionnaire MCREO (french version) will be used to evaluate patients in the occupational aspect.

Trial Locations

Locations (1)

Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP; 🇫🇷 Garches, France