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临床试验/NCT04635709
NCT04635709已完成1 期

Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis

Taibah University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月15日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Detruser pressure between and within groups

研究概览

简要总结

study the effect of behavioral therapy and interferential current on management of bladder dysfunction in patients with multiple sclerosis

详细描述

Fifty patients with multiple sclerosis (MS) (secondary progressive type SPMS) suffering from bladder dysfunction were divided equally into two groups randomly; Group A received biofeedback training (behavioral therapy) while group B received interferential training. Both groups were assessed by urodynamics for detrusor pressure and maximum flow rate before and after eight weeks of behavioral therapy and interferential training.

Data analysis was managed using SPSS for windows, version 22 (SPSS, Inc., Chicago, IL). The current test involved two independent variables. The first one was the (tested group); between subject factors which had two levels (group A received behavioral therapy and group B who received IF ) .The second one was the (measuring periods); within subject factor which had two levels (pre, post). In addition, this test involved two tested dependent variables (detrusor pressure and maximum flow rate ) .T independent and dependent tests were used to compare between and within groups respectively. Data was considered statistically significant when P < .05

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •All the patients were referred by a neurologist and the diagnosis was confirmed by the Magnetic Resonance Image (MRI).The duration of being diagnosed as SPMS for both groups were between one to two years. All the selected patients had normal mental examination according to mini mental scale .Also, all the selected patients were medically stable.

排除标准

  • •Patients with any other neurological deficits or orthopedics abnormalities or with auditory dysfunction were excluded from this study. Patients with history of bladder dysfunctions before the diagnosis of MS or attaining any attack during the treatment period were also excluded.

研究组 & 干预措施

behavioral therapy

Experimental

applying biofeedback training on the pelvic floor muscles

干预措施: biofeedback training and interferential therapy (Device)

interferential therapy (IF)

Experimental

Interferential current was applied to the body using four surface electrodes placed on the lower abdomen and lower buttocks.

干预措施: biofeedback training and interferential therapy (Device)

结局指标

主要结局

Detruser pressure between and within groups

时间窗: eight weeks

test it by urodynamic test before and after management

Maximum flow rate between and within groups

时间窗: eight weeks

test it by urodynamic test before and after management

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

walaa M Ragab

DR

Taibah University

研究点 (1)

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