Time to be Ready to Void: a New Tool to Assess the Time Needed to Perform Micturition in Multiple Sclerosis

NCT04024085 | Completed

• 1 other identifier: GRC-001 GREEN
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to create a specific test to assess the global time required to go to the toilet and to perform micturition, at the moment the patient decides to urinate in multiple sclerosis population, and to assess its reliability.

Conditions

Gait Disorders, Neurologic; Urinary Incontinence, Urge; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Total time for TRV

  The participants have to stand up from a chair with armrests, walk 6 meters to the toilet, open the door and turn on the light, close the door, undress and position themselves to urinate. All the test is timed

  1 day

Secondary Outcomes (2)

• Time for the first stage: "mobility" stage

  1 day

• Time for the second stage: "settled" stage

  1 day

Study Arms (1)

Participants

adult with a multiple sclerosis diagnosis, able to walk 50 meters without human help, Expanded Disability Status Scale (EDSS) \< 7, consulting in a neuro-urology department

Other: completion of the test created Time to be Ready to Void

Interventions

completion of the test created Time to be Ready to Void OTHER

completion of the test created (Time to be Ready to Void) The participants have to stand up from a chair with armrests, walk 6 meters to the toilet, open the door and turn on the light, close the door, undress and position themselves to urinate

Participants

Eligibility Criteria

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

Study Population

patients with multiple sclerosis who were consulting in neuro-urology department

You may qualify if:

• adult with a multiple sclerosis diagnosis,
• able to walk 50 meters without human help,
• Expanded Disability Status Scale (EDSS) \< 7

You may not qualify if:

• relapse of multiple sclerosis in the last 7-days,
• acute urinary tract infection

Sponsors & Collaborators

• Gérard Amarenco: lead

Study Sites (1)

department of Neuro-Urology, Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Urinary Incontinence, Urge; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gérard Amarenco, PhD

  Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Neuro-Urology department, Tenon Hospital

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: March 13, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)