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临床试验/NCT05587101
NCT05587101招募中不适用

Optimal Diagnostic Algorithm for Neurogenic Lower Urinary Tract Symptoms in Patients With MS

Koç University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Changes in Urodynamics

研究概览

简要总结

There is no consensus in the literature upon the neurourological diagnostic algorithm of the patients with multiple sclerosis (MS). The primary aim of the study is phenotyping the patients with MS. These phenotypes might guide Neurology and Urology specialists during diagnosis and treatment. Secondary aim of this study is to define the presence and severity of urological symptoms' and disorders', involving the patients with diagnosis of MS less than 5 years into a urological follow-up and treatment process. Our study might include 4 visits (the first visit, 3rd month, 6th month and 12th month visit). Questionnaires, uroflowmetry and bladder diary might be repeated on each visit. Filling cystometry and pressure-flow study will be performed only on the first visit. All patients will receive 6 different questionnaires which aim to define the severity and presence of lower urinary tract symptoms. Bladder diary is an online application which will represent at least 3 days of frequency, urgency, incontinence episodes and the amount of fluid intake, and urination. The phenotypes would be defined after performing the first visit diagnostic tools (all of the tools are necessary during the diagnostic algorithm of neurogenic lower urinary tract symptoms). The phenotypes will be defined as: a. no symptoms with normal urodynamics, b. Lower urinary tract symptoms with normal urodynamics, c. no symptoms with abnormal urodynamics, d.lower urinary tract symptoms with abnormal urodynamics. During a follow-up period of 1 year, changes in the bladder diaries and scores in questionnaires of these groups will be compared on each visit.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The patients who are followed up by Department of Neurology with MS diagnosis less than 5 years

排除标准

  • •Patients who are not eligible for completing questionnaires, bladder diaries.
  • •Patients who have anatomical disorders preventing lithotomy position during urodynamic study.
  • •Patients in relapsing period of MS
  • •Patients who have symptoms of urinary tract infection

结局指标

主要结局

Changes in Urodynamics

时间窗: every 3 months

Bladder dysfunction

Changes in Questionnaire Scores

时间窗: every 3 months

Bladder dysfunction

次要结局

未报告次要终点

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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