跳至主要内容
临床试验/NCT04364438
NCT04364438Unknown不适用

A Randomized Controlled Trial on Effectiveness of Electric Muscle Stimulation (EMS) and Transcutaneous Electric Nerve Stimulation (TENS) in Patients With Overactive Bladder

Isra University1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2020年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
315
试验地点
1
主要终点
Overactive Bladder Scoring System (Change is being assessed)

研究概览

简要总结

Overactive bladder (OAB) syndrome is a well-recognized set of symptoms which patient experience during the storage phase of the micturition cycle. It is characterized by urgency (a sudden compelling desire to pass urine which is difficult to defer) which, in almost all patients, is accompanied by increased frequency and nocturia and, particularly in female patients, by urgency incontinence.

详细描述

Leaking urine is called "incontinence". Stress urinary incontinence (SUI), is another common bladder problem. It's different from OAB. People with SUI leak urine while sneezing, laughing or doing other physical activities. If you have an overactive bladder, you may feel embarrassed, isolate yourself, or limit your work and social life.

Overactive bladder (OAB) is a very common clinical condition, with an overall prevalence estimated at 11.5% in the general population of Pakistan.

In traditional medicine and recent years, nerve stimulation has been introduced as a replacement therapy for managing several disorders such as overactive bladder. However, there is still controversy in this regard. Therefore, the present study is aimed to find out the effectiveness of Electric Muscle Stimulation and Transcutaneous Electric Nerve Stimulation in treatment of overactive bladder.To overcome this controversy we need to do this study in Pakistan and find out whether there is any role of EMS and TENS in the management of OAB.

OAB is one of the important conditions that lead to the limitation in activity and participation due to dribbling, urgency and frequency of urination. According to literature review there is a strong linkage between OAB rehabilitation and improvement of patient symptoms. The Neuromodulation plays a significant role in the management of OAB. The proper task specific rehabilitation not only improves the functional status of a person rather it enhances the quality of life and their active role in community. In routine rehabilitation main focus is always on the role of pelvic floor exercises but Neuromodulation is still neglected in treatment regimen of OAB in Pakistan. The patients will profit in better help of manifestations if Neuromodulation intervention is applied that is upheld by proof for the treatment of OAB. The consequences of the investigation will be useful for the Physical Therapists in planning and picking best treatment approach for the treatment of OAB.

TENS is based on the gate control theory of abolishing the local micturition reflex arc. It is a non-pharmacological method of inhibiting the presynaptic afferent neurons carrying impulses from bladder by stimulating the nerves of peripheral segmental dermatome (gate control theory of electro modulation by stimulating the peripheral nerves corresponding to the visceral organ). It acts at the level of primitive voiding reflex coordinating the bladder, sphincter and the pelvic floor. Detrusor hyperreflexia can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron or by inhibition of bladder preganglionic neurons of the efferent limb of micturition reflex.

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
Single (Participant)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both Male and Female patients ≥35years to 60 years with OAB symptoms of urgency, frequency, nocturia and urgency urinary incontinence (UUI).8
  • •Those who have symptoms of urinary frequency and urgency lasting more than 3 months.
  • •Those who have an average urinary frequency of more than eight times per day and urgency defined by the urgency rating scale (URS) on the bladder diary of more than 2 points. 9

排除标准

  • •Diagnosed with Urinary Tract Infection by urine examination.
  • •Stress urinary incontinence without symptoms of OAB.
  • •History of cystocele, uterine prolapse or similar condition.
  • •History of obstructive uropathy such as urinary stones and urinary tumors.
  • •Malignancy

研究组 & 干预措施

Control Group

No Intervention

Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises

EMS Group

Experimental

Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises along with Electric Muscle Stimulation (EMS)

干预措施: Electric Muscle Stimulation (Device)

TENS Group

Experimental

Patients will be treated with conventional medical treatment for overactive bladder including anticholinergic drugs and pelvic floor muscle exercises along with Transcutaneous Electric Nerve Stimulation (TENS)

干预措施: Transcutaneous Electric Nerve Stimulation (Device)

结局指标

主要结局

Overactive Bladder Scoring System (Change is being assessed)

时间窗: Baseline and week 12

The Overactive Bladder Scoring System is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score. The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. Initial results will be measured by using overactive bladder scoring system. After 12 weeks ( Completion of Treatment) patients will be re evaluated for their symptoms and graded again by using overactive bladder scoring system. A comparison will be made among data obtained from 03 groups to check the effectiveness of intervention

次要结局

  • King's Health Questionnaire (Change is being assessed)(Baseline and week 12)

研究者

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

Sajid rashid

Principal Investigator

Isra University

研究点 (1)

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