Is the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis

Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor impairment, ataxia, sensitive disorders, fatigability…). Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with MS duration and severity of neurological deficiencies and disabilities. Overactive bladder (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life, the severity of LUTSs has never been studied as specific risk factor of falling. However, urinary urgency and urinary incontinence could lead to precipitation and thus could increase the risk of falling in these patients.

The aim of the study was to assess the relationship between severity of LUTSs and risk of falling in PwMS.

Patients were asked about the number of falls in the past three months and in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms Profile (USP) Score and patient were classified as with or without urinary incontinence. Number of micturition by night were specifically asked. To take into account motor difficulties and fear of falling, other clinical evaluations were done. The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire.

The primary aim was to assess the relationship between severity of LUTSs and occurrence of falls during the past 3 months. The primary outcome was the importance of overactive bladder (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary incontinence, the warning time (defined as the time from the first sensation of urgency to voiding or incontinence), the importance of nocturia and the other scores of USP questionnaire (low stream and stress urinary incontinence).

The secondary aims were to look for the relationship between severity of LUTSs and occurrence of falls during the past year, and to assess the relationship between falls and the classical risk factors of falls.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms; Fall
• Intervention / Treatment: Other: Clinical tests

• Study Type: Observational
• Enrollment (Actual): 150

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: Non-Probability Sample

Study Population

Patients consulting in a tertiary center in neuro-urology

Description

Inclusion Criteria:

• age ≥ 18 years
• Multiple sclerosis (MS) diagnosis
• Lower urinary tract symptoms with or without treatment,
• Expanded Disability Status Scale score between 1 and 6.5

Exclusion Criteria:

• relapse of MS in the past month
• urinary tract infection the day of inclusion
• impossibility to complete the symptoms' questionnaires

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients enrolled; Patient with multiple sclerosis and lower urinary tract symptoms, age >18 Expanded Disability Status Scale score between 1 and 6.5	Other: Clinical tests; Questionnaire about urinary symptoms, gait difficulties, fear of falling. Clinical test: Time to be Ready to Void

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls in the past 3 months	Patients were asked about the number of falls in the past three months, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of falls in the past year	Patients were asked about the number of falls in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia)	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between number of falls in the past 3 months and in the past year and clinical datas and characteristics of the patient	The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the EDSS score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire	1 day

Collaborators and Investigators

• Sponsor: Gérard Amarenco

Publications and helpful links

General Publications

• Hentzen C, Villaume A, Turmel N, Chesnel C, Le Breton F, Haddad R, Amarenco G. Are falls in people with multiple sclerosis related to the severity of urinary disorders? Ann Phys Rehabil Med. 2021 Jul;64(4):101452. doi: 10.1016/j.rehab.2020.10.006. Epub 2020 Dec 5.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: April 4, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 8, 2020

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

• Keywords: overactive bladder; multiple sclerosis; Fall; lower urinary tract symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urological Manifestations; Multiple Sclerosis; Sclerosis; Lower Urinary Tract Symptoms
• Other Study ID Numbers: GREEN GRC01 P

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