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

NCT04338646 | Completed

• 1 other identifier: GREEN GRC01 P
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fall; Multiple Sclerosis; Lower Urinary Tract Symptoms

Keywords

Fall; multiple sclerosis; lower urinary tract symptoms; overactive bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of falls in the past year

  1 day

Other Outcomes (1)

• Correlation between number of falls in the past 3 months and in the past year and clinical datas and characteristics of the patient

  1 day

Study Arms (1)

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

Interventions

Clinical tests OTHER

Questionnaire about urinary symptoms, gait difficulties, fear of falling. Clinical test: Time to be Ready to Void

Patients enrolled

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

Patients consulting in a tertiary center in neuro-urology

You may qualify if:

• 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

You may not qualify if:

• relapse of MS in the past month
• impossibility to complete the symptoms' questionnaires

Sponsors & Collaborators

• Gérard Amarenco: lead

Study Sites (1)

department of Neuro-Urology, Hôpital Tenon

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 33186783 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital 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: April 4, 2020
• First Posted: April 8, 2020
• Study Start: July 1, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 30, 2020
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)