Hôpital TENON
Paris, Choisir Une Région, 75020, France
Location status: Recruiting
NCT Number: NCT05772637
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Paris, Choisir Une Région, 75020, France
Location status: Recruiting
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 multiple sclerosis (MS) duration and the severity of the neurological deficiencies and disabilities. Overactive bladder (OAB) with urgency, frequency, urgency urinary incontinence, is the most common symptom, reported by 37-99% of the PwMS. Voiding difficulties are less common, from 6 to 49%, and usually appear later with the course of the disease.
Urodynamics is a useful test recommended to understand the mechanism of bladder dysfunction, and look for risk factors of upper tract damage.
Detrusor overactivity is the most reported mechanism of overactive bladder, and describes the occurrence of uninhibited contractions of the detrusor during bladder filling. But abnormal bladder sensations, with increased or decreased sensations, have also been described. The prevalence of these abnormalities is not well described, however, in the absence of detrusor overactivity, abnormal afferent information (i.e., abnormal bladder sensations) is the plausible mechanism involved in urinary disorders.
The assessment of bladder sensations is still a poorly explored field. Bladder diary can be used for the collection of the intensity of need to void with a Likert scale or numerical scale.
During cystometry, it is recommended to collect different bladder sensations: first sensation of filling, first desire to void, strong desire to void, urgent desire to void. However, it has been described that bladder sensations progress in 8 to 9 different levels of intensity in healthy subjects.
The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of OAB in patients with multiple sclerosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A second cystometry will be performed to assess bladder sensations reliability. A third cystometry with cognitive task (STROOP test) at the same time will be performed to assess the impact of distractive attentional task on bladder sensations
Time frame: Day 1
The areas under the sensation-capacity curve (AUC) will be calculated for individual participants using the trapezoidal rule for specific capacity ranges.
Time frame: Day 1
Bladder sensitivity assessed by the number of steps in the evolution of the need to urinate reported by the patient (number of times the cursor of the analogical scale is moved), during the filling.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: CUBS-MS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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