An observational study in Multiple Sclerosis, Constipation and Fecal Incontinence, sponsored by Pierre and Marie Curie University. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by Pierre and Marie Curie University · Observational
Among 376 studies in Multiple Sclerosis with a site in France — 64 open to participants now, 93 under way, 18 of them phase 3. Multiple Sclerosis · France.
Among the 376 studies in Multiple Sclerosis with a site in France, this one is the 57th largest by enrollment of the 132 observational ones that give a count, is one of 29 that started in 2019, is one of 132 observational ones, and was the 278th registered.
3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.
Browse Multiple Sclerosis studies →64 of the 376 studies in Multiple Sclerosis with a site in France are open now. Recruiting first, the newest first:
University Hospital, Lille · Sites in France
Ages 18–65
University Hospital, Montpellier · Sites in France
Ages 40+
University Hospital, Caen · Sites in France
Ages 18+
Otto Bock France SNC · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
376 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 28 · Phase 3 77 · Phase 4 25
First in 1999; this study’s year is marked. 29 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 200 is above the median of 100 across 971 observational studies indexed under Multiple Sclerosis.
Median enrollment 144 across the 244 interventional studies, 174 across the 132 observational. Of the 253 that completed or were terminated, 69 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
130 of 376 have an industry lead sponsor. The 10 most frequent:
Pierre and Marie Curie University is the lead sponsor of 23 studies on the registry; none are open to participants now.
Pierre and Marie Curie University has 4 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
18 of the studies in Multiple Sclerosis with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT03653273Phase 3Rennes University HospitalDisease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP) | 2027-07 |
| NCT05519553Nantes University HospitalPeer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis | 2026-12-01 |
| NCT07108088ÖSSUR FranceEvaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application | 2026-12-31 |
| NCT05772637Assistance Publique - Hôpitaux de ParisClinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis | 2027-02-14 |
Add all 18 to your calendar (.ics) → With an account.
Among the 376 studies in Multiple Sclerosis with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Multiple sclerosis (MS) is an autoimmune autoimmune central nervous system (CNS) disorder characterized by demyelinisation and central neurologic damage. MS is the first cause of disability in young adults and affects 2.8 million people in the world.
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. Chronic constipation and fecal incontinence were defined by Rome IV criteria. According to these criteria, constipation is a bowel disorder in which symptoms of difficult, infrequent, or incomplete defecation predominate for at least 3 months and fecal incontinence is defined as the recurrent uncontrolled passage of fecal material for at least 3 months.
Moreover, neurogenic bowel dysfunction has a real impact on quality of life and can cause social isolation.
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. All these phases allowed a full psychometric validation of the questionnaire.
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.
Step 1: literature review and qualitative interview. The investigators conducted a review of literature on Pubmed to know all the existing questionnaires or tools developed and validated to assess neurogenic bowel dysfunction in MS. All articles published until April 2020 were included. The following keywords were used: "neurogenic bowel dysfunction", "constipation", "fecal incontinence", "anorectal disorders", "multiple sclerosis".
In addition a single trained nurse performed qualitative interviews with patients suffering from ano rectal disorders secondary to MS. These interviews were lead in two phases. First part allowed to determine the wording of the different symptoms and mode of response for each item. The second part of the face-to-face was free and patients could express themselves if there was a gap in our list of symptoms.
During this first phase of the study a panel of 8 experts was selected, composed of neuro urologists and gastro enterologists.
The first version of the questionnaire was made based on the patients' qualitative interviews, on the reactions and comments of the expert team and on the literature review.
Step 2: Feasibility study The feasibility study was conducted between April 2020 and June 2020. This pilot study included 30 patients and was performed to assess comprehension, acceptability and pertinence of the items the investigators have created to build the questionnaire. More of response was also evaluate by patients.
Step 3: Validation study. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool. All items were discussed for ceil or floor effect by the expert team. Each item with more than 50% of patients having the same response were discussed by panel experts to decide if they were excluded or not of the final version.
To obtain good psychometric properties, the investigators included 10 patients for each items of the questionnaire in the final version. This number of subjects was calculated to allow univariate and multivariate logistic regression.
Internal consistency reliability was calculated using the alpha coefficient of Cronbach. Each response has been transformed in a numeric value to perform this test. Alpha coefficient of Cronbach was considered as very good if > 0.7.
Test-retest reliability was tested using the intraclass correlation coefficient (ICC) which was significant over 0.7. The first questionnaire was filled at the end of the first consultation and patients had to mail a second questionnaire (filled at home) 7 to 14 days after the first consultation.
Statistical analyses: Final version of STAR-Q (Symptoms and Treatment Assessment of Ano-Rectal disorders in multiple sclerosis patients Questionnaire) was composed by 3 sub domains. First one was symptoms, second one was treatment, and a third sub domain was quality of life.
For each sub domains, the investigators calculated an alpha coefficient of Cronbach and a ICC. the investigators also assessed these properties for total score.
Total score was compared to NBD total score which represents gold standard in ano rectal disorders and thus constitutes the reference testing external consistency. Finally, PGI (Patient Global Improvment) severity scores were used to determine category of severity for STAR-Q scores.
All statistical analyzes were performed with the R-studio version 3.3.1 and Statviews (SAS institute V 5.0).
Patients consulting or hospitalized in a rehabilitation center or in a neuro-urology center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with Multiple sclerosis, with an age older than 18 years old and symptoms of fecal incontinence or chronic constipation
Other: Clinical interviews
Semi-qualitative interviews and questionnaire STAR-Q
Also known as: Semi-qualitative interviews and questionnaire
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.
Time frame: 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.
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Jul 2020, 13 months.
Of 335 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 81. This study's 13 months is below that.
Counting every sponsor, half of 426 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pierre and Marie Curie University