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

NCT05475093 | Completed

• 2 other identifiers: APHP2202652021-A02637-34
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Medullary Injury; Micturition Disorder

Keywords

Medullary Injury; Micturition modes; Quality of life; Human occupation

Outcome Measures

Primary Outcomes (2)

• 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

• Model of human occupation

  Questionnaire MCREO (french version) will be used to evaluate patients in the occupational aspect.

  at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with medular injury who have their follow-up care in the neuro-urology unit in raymond poincaré hospital, live at home or in long-term care facility definitively.

You may qualify if:

• Adult patients with spinal cord injury;
• Live at home or in long-term care facility definitively;
• Have one of the following urination modes:
• urine with indwelling catheter in place
• catheter in suprapubic area
• intermittent catheterization by urethra
• intermittent catheterization by incontinent cystostomy
• sphincterotomy
• incontinent stomia (Bricker)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP

Garches, 92380, France

Location

MeSH Terms

Conditions

Urination Disorders

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexia EVEN, MD

  Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP

  PRINCIPAL INVESTIGATOR

• Aurélie -Anna DUBOIS

  Neuro-Urology Unit, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, APHP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: July 22, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)