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

Micturition Disorder Clinical Trial

— URO-ActSCi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475093
• Other study ID #: APHP220265
• Secondary ID: 2021-A02637-34
• Status: Completed
• Start date: July 22, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Micturition Disorder
• Urination Disorders
• Wounds and Injuries

Locations

Country	Name	City	State
France	Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life by QUALIVEEN-30	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.	at baseline
Primary	Model of human occupation	Questionnaire MCREO (french version) will be used to evaluate patients in the occupational aspect.	at baseline