Prospective Randomized Controlled Trial Comparing the Non-invasive vs the Invasive Investigations in Multiple Sclerosis Patients With Urinary Disorders.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- urinary symptoms
研究概览
简要总结
The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.
详细描述
All patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly.
An evaluation will be made one month, 3 months and 6 months after the first visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS with urinary symptoms
排除标准
- •Bladder cancer
- •prostate cancer
- •urethral stenosis
研究组 & 干预措施
Non-invasive investigations group
Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry
干预措施: Non-invasive investigations (Diagnostic Test)
Invasive investigations group
urodynamic study including: cystomanometry, pressure flow study, EMG
干预措施: Non-invasive investigations (Diagnostic Test)
Invasive investigations group
urodynamic study including: cystomanometry, pressure flow study, EMG
干预措施: Invasive investigations (Diagnostic Test)
结局指标
主要结局
urinary symptoms
时间窗: 6 months
filling and voiding urinary symptoms (UBQMS: Urinary Bothersome Questionnaire in Multiple Sclerosis), Voising Score Ranges from 0 to 3 ( 3 being most severe bother), Filling score ranges from 0 to 3 ( 3 being most severe bother).
urinary quality of life
时间窗: 6 months
SF-QUALIVEEN: Short Form - health related quality of life questionnaire for urinary disorders in patients with neurological conditions. score ranges from 0 to 4 ( 4 being the worst quality of life).
次要结局
未报告次要终点