Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q

NCT04996186 | Completed

• 1 other identifier: GRC 01 GREEN STAR Q
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction. Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool developed in MS patients. Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in neurogenic bowel dysfunction and frequently coexist in this population, generally in association with urinary disorders. Because of the high prevalence of bowel disorders their and the major impact on the quality of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum (persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used in research for all neurologic patients despite its lack of sensibility in various neurogenic population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014, there is a need of a specific evaluation for bowel symptoms in neurogenic population, especially for PwMS. The aim of the study was to create and validate a new multidimensional questionnaire to assess bowel dysfunction and impact on quality of life in patients with MS. The investigators conducted a prospective multicenter study (8 centers) between June 2019 to April 2021. This study was developed in 3 steps. First step was literature review and qualitative interview. Then the second step was the feasibility study to evaluate comprehension, acceptability of the different items. The last part of the study was the validation study of the questionnaire. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool. Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria were included. Patients not able to read or understand the objectives and procedures for conducting the protocol and patient who had a recent relapse of MS were excluded.

Conditions

Multiple Sclerosis; Constipation; Fecal Incontinence

Keywords

multiple sclerosis; constipation; fecal incontinence; questionnaire; evaluation; quality of life

Outcome Measures

Primary Outcomes (2)

• Reproductibility of STAR-Q

  Patients were asked to answer a second time the questionnaire with a second evaluation at 14 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC \> 0.70 was necessary to define reproducibility.

  1 day

• Acceptability and comprehension of STAR-Q

  Each patient was asked to rate each version of the 22 questions with a four-point Likert scale (A: perfect, B: good, C: average, D: bad) regarding acceptance and comprehension of the questions.

  1 day

Study Arms (1)

Patients enrolled

Patients with Multiple sclerosis, with an age older than 18 years old and symptoms of fecal incontinence or chronic constipation

Other: Clinical interviews

Interventions

Clinical interviews OTHER

Semi-qualitative interviews and questionnaire STAR-Q

Also known as: Semi-qualitative interviews and questionnaire

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 or hospitalized in a rehabilitation center or in a neuro-urology center

You may qualify if:

• Patients with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria
• over 18 years old

You may not qualify if:

• inability to read and to understand the questions
• recent relapse of multiple sclerosis

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

Department of Neuro- Urology, Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Constipation; Fecal Incontinence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gérard Amarenco, PHD

  Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, F-75020, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of neurourology department, APHP, Tenon Hospital, Paris, France

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: June 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: April 30, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

FR (1)