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临床试验/NCT05772637
NCT05772637
招募中
不适用

Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2024年2月14日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
113
试验地点
1
主要终点
bladder sensation ( area under the sensation-capacity curve (AUC))

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

MS Patient with Bladder disorders

Experimental

干预措施: Repeated cystometries with bladder sensations assessment (Procedure)

结局指标

主要结局

bladder sensation ( area under the sensation-capacity curve (AUC))

时间窗: Day 1

The areas under the sensation-capacity curve (AUC) will be calculated for individual participants using the trapezoidal rule for specific capacity ranges.

次要结局

  • bladder sensitivity(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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