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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338646
• Other study ID #: GREEN GRC01 P
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: February 2022
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 30, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall
• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	department of Neuro-Urology, Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Gérard Amarenco

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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