The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
研究概览
简要总结
This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder
详细描述
Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessor and investigator that assesses the patients will be blind to the study groups
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than
- •Post voiding residue levels less than 100 ml.
- •Women aged between 18-70
排除标准
- •Prior history of pelvic surgery
- •Pelvic organ prolapsus of grade 2 or more.
- •Current urinary tract infection
研究组 & 干预措施
Transcutaneous tibial nerve stimulation plus bladder training
Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.
干预措施: Bladder training (Behavioral)
Transcutaneous tibial nerve stimulation plus bladder training
Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.
干预措施: Transcutaneous tibial nerve stimulation (Device)
Bladder training
patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.
干预措施: Bladder training (Behavioral)
结局指标
主要结局
Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
时间窗: 1 day
This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.
Urination frequency
时间窗: 1 day
The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.
次要结局
- Quality of life. King's quality of life questionnaire(1 day)
- Level of satisfaction with the treatment. Visual analog scale(1 day)
- Incontinence impact questionnaire-7.(1 day)