Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04024085 |
| Other study ID # |
GRC-001 GREEN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2019 |
| Est. completion date |
July 31, 2019 |
Study information
| Verified date |
February 2022 |
| Source |
Pierre and Marie Curie University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of the study is to create a specific test to assess the global time required to go to
the toilet and to perform micturition, at the moment the patient decides to urinate in
multiple sclerosis population, and to assess its reliability.
Description:
Lower urinary tract symptoms (LUTS) are frequent in central nervous system disorders
especially in patients with multiple sclerosis (PwMS). Prevalence of LUTS is important (32 to
96.8%) and increases with the multiple sclerosis (MS) duration and the severity of the
neurological deficiencies and disabilities. Overactive bladder with urgency, frequency, urge
incontinence, is the most common symptom, reported by 37-99% of the PwMS. OAB not only
impacts quality of life but overactive detrusor associated with detrusor sphincter
dyssynergia can lead to upper urinary tract alteration (reflux, dilatation, urinary tract
infection). In the absence of risk factor, the treatment aims to improve comfort and quality
of life. Anticholinergic drugs are usually the first-line treatment, but their frequent
adverse effects (constipation, xerostomia, cognitive impairment) may impact compliance and
adherence. The warning time (defined as the time between the first desire to void and the
micturition impossible to defer) only partially reflects the possibilities of continence.
Indeed, other numerous and various factors such as patient mobility, autonomy for transfers,
speed of undressing, etc., can influence the global time between the first alert (first
desire to void) and the imperious micturition and thus on the risk of incontinence.
The global time required to go to the toilet and undress is difficult to quantify and no
specific and validated test is available for this.
The aim of the study is to create a specific test to assess the global time required to go to
the toilet and to perform micturition, at the moment the patient decides to urinate in
multiple sclerosis population, and to assess its reliability.
In this study, the investigators develop a new tool to assess the global time required to go
to the toilet until patients are ready to void: Time to be Ready to Void (TRV). The different
stages to go to the toilet are individualized, and two prior steps are defined: a mobility
stage starting when the examiner gives the starting signal, includes the stand up, the walk
to the toilets, and stops when the patient puts his hand on the door handle; and a settled
stage starting as soon as the subject has his hand on the door handle, until he is undressed
and in his usual and secure position to void. The "interval" or "lap" function of the
chronometer is used to facilitate the recording. Difficulty of each stage is assessed by a
4-point Likert type scale with 3 indicating ''no difficulty'' and 0 indicating ''impossible
or necessitate human help".
This study was approved by the local ethics review board RCB: 2018-A01644-51. Participants
will be recruited in a Neuro-urology department during a medical appointment, an urodynamic
assessment, or a day hospital related to urinary disorders.
Data collected are:
- Medical history
- Age
- Sex
- EDSS score
- Urinary Symptom Profile score
- Data of the last urodynamic
- need to void with numerical scale between 0 and 10 before the test
To assess inter-rater reliability, two examiners record the first TRV try with both a digital
chronometer. To assess reliability of the TRV, a second try is done after at least 10 minutes
of rest, with one of the two examiners, checking that the need to void has not changed
significantly.
To assess the internal consistency of the TRV, further tests are carried out:
- a 10-meter walk test (10MWT) at maximum speed
- a Timed Up and Go (TUG)
- a Tinetti Mobility Test
- the self-questionnaire Fall Efficacy Scale International for balance evaluation
- a bilateral Nine Hold Peg (NHP) Test for dexterity
- the Functional Independence Measure (FIM) score
- the Katz - activities of daily living index (Katz ADL)
Statistical analyses will be performed with the R software for Windows (Rx64 3.2.3, R
Foundation for Statistical Computing, Vienna, Austria). Descriptive data will be presented as
means with SD for continuous data and as medians with range for ordinal data and data not
normally distributed.
Inter-rater reliability and test-re test reliability will be assessed using intra-class
correlation coefficient (ICC, absolute agreement). Internal consistency with the
complementary tests will be assessed using Spearman correlation.
