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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Gait Disorders, Neurologic; Urinary Incontinence, Urge
• Intervention / Treatment: Other: completion of the test created Time to be Ready to Void

Detailed Description

Lower urinary tract symptoms (LUTS) are frequent in central nervous system disorders especially in patients with multiple sclerosis (PwMS). Prevalence of LUTS is important (32 to 96.8%) and increases with the multiple sclerosis (MS) duration and the severity of the neurological deficiencies and disabilities. Overactive bladder with urgency, frequency, urge incontinence, is the most common symptom, reported by 37-99% of the PwMS. OAB not only impacts quality of life but overactive detrusor associated with detrusor sphincter dyssynergia can lead to upper urinary tract alteration (reflux, dilatation, urinary tract infection). In the absence of risk factor, the treatment aims to improve comfort and quality of life. Anticholinergic drugs are usually the first-line treatment, but their frequent adverse effects (constipation, xerostomia, cognitive impairment) may impact compliance and adherence. The warning time (defined as the time between the first desire to void and the micturition impossible to defer) only partially reflects the possibilities of continence. Indeed, other numerous and various factors such as patient mobility, autonomy for transfers, speed of undressing, etc., can influence the global time between the first alert (first desire to void) and the imperious micturition and thus on the risk of incontinence.

The global time required to go to the toilet and undress is difficult to quantify and no specific and validated test is available for this.

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.

In this study, the investigators develop a new tool to assess the global time required to go to the toilet until patients are ready to void: Time to be Ready to Void (TRV). The different stages to go to the toilet are individualized, and two prior steps are defined: a mobility stage starting when the examiner gives the starting signal, includes the stand up, the walk to the toilets, and stops when the patient puts his hand on the door handle; and a settled stage starting as soon as the subject has his hand on the door handle, until he is undressed and in his usual and secure position to void. The "interval" or "lap" function of the chronometer is used to facilitate the recording. Difficulty of each stage is assessed by a 4-point Likert type scale with 3 indicating ''no difficulty'' and 0 indicating ''impossible or necessitate human help".

This study was approved by the local ethics review board RCB: 2018-A01644-51. Participants will be recruited in a Neuro-urology department during a medical appointment, an urodynamic assessment, or a day hospital related to urinary disorders.

Data collected are:

• Medical history
• Age
• Sex
• EDSS score
• Urinary Symptom Profile score
• Data of the last urodynamic
• need to void with numerical scale between 0 and 10 before the test

To assess inter-rater reliability, two examiners record the first TRV try with both a digital chronometer. To assess reliability of the TRV, a second try is done after at least 10 minutes of rest, with one of the two examiners, checking that the need to void has not changed significantly.

To assess the internal consistency of the TRV, further tests are carried out:

• a 10-meter walk test (10MWT) at maximum speed
• a Timed Up and Go (TUG)
• a Tinetti Mobility Test
• the self-questionnaire Fall Efficacy Scale International for balance evaluation
• a bilateral Nine Hold Peg (NHP) Test for dexterity
• the Functional Independence Measure (FIM) score
• the Katz - activities of daily living index (Katz ADL)

Statistical analyses will be performed with the R software for Windows (Rx64 3.2.3, R Foundation for Statistical Computing, Vienna, Austria). Descriptive data will be presented as means with SD for continuous data and as medians with range for ordinal data and data not normally distributed.

Inter-rater reliability and test-re test reliability will be assessed using intra-class correlation coefficient (ICC, absolute agreement). Internal consistency with the complementary tests will be assessed using Spearman correlation.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • department of Neuro-Urology, Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for the first stage: "mobility" stage	, the "mobility" stage, starting when the examiner gives the starting signal, includes the stand up, the walk to the toilets, and stops when the patient puts his hand on the door handle	1 day
Time for the second stage: "settled" stage	the "settled" stage starts as soon as the subject has his hand on the door handle, until he is undressed and in his usual and secure position to void	1 day

Collaborators and Investigators

• Sponsor: Gérard Amarenco

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Urination Disorders; Multiple Sclerosis; Sclerosis; Urinary Incontinence; Nervous System Diseases; Gait Disorders, Neurologic; Urinary Incontinence, Urge
• Other Study ID Numbers: GRC-001 GREEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No