Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Repeated cystometries with bladder sensations assessment.
- Кому может быть актуально
- Состояния в реестре: Overactive Bladder. Базовые параметры: 18 лет — 99 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Repeated cystometries with bladder sensations assessment
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
Первичные конечные точки
- bladder sensation ( area under the sensation-capacity curve (AUC)) [Срок оценки: Day 1]
Вторичные конечные точки (1)
- bladder sensitivity [Срок оценки: Day 1]
Критерии участия
Критерии включения
- Age ≥ 18
- MS according to the 2017 Mac Donald diagnostic criteria
- Bladder disorders supposedly related to MS
- Indication to perform urodynamics
- No current medication for bladder disorders
- Able to understand and right in French
- Affiliated to the "Securite sociale" or "Couverture Medicale Universelle (CMU)", or equivalent organism.
Критерии исключения
- Legal protection
- Pregnancy or breastfeeding mother
- MS relapse during the past month
- Other associated neurological disease
- Genuine stress incontinence related to postpartum
- Treatment with antimuscarinics, alpha blockers, beta3 adrenergic, or tibial nerve stimulation in the past 15 days, or with botulinic toxin injection in the past 6 months
- Previous lower urinary tract surgery
- Inability to use the analogic device due to motor, sensory or ataxic disabilities
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 1 центр
- Hôpital TENON — Paris
Идентификаторы
NCT: NCT05772637 · APHP230079