Comparing the efficacy of para-sacral Trans-cutaneous electrical Nerve Stimulation(TENS) with medical management in the treatment in children with Over-Active Bladder(OAB) - A prospective randomized study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To show significant improvement in symptoms post administration of Trancutaneous electrical Nerve Stimulation
研究概览
简要总结
Overactive bladder encompasses a wide range of conditions in children which present with incontinence. Overactive bladder in children often causes urgency, frequency, incontinence and daytime wetting leading to low self-esteem & depression in school going children. Over active bladder (OAB) is a symptom complex consisting of urgency, with or without urge incontinence, usually with frequency and nocturia. The prevalence of overactive bladder is 5–12% in children and 0.5% in adolescents with a slight male preponderance.
It is possible that TENS is more effective than current medical management in overactive bladder as children could be more compliant, due to the ease of the procedure and lack of side effects. In future TENS may also become useful in other groups of secondary bladder dysfunction – like valve bladders, neurogenic bladders etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 5-18 years •Lower urinary tract symptoms of recent onset •Bowel symptoms evaluated and treated.
排除标准
- •Neurological abnormality (X- ray Spine) •Obstructive uropathy (Ultrasound of Kidney Ureter Bladder) •Active Urinary Tract Infection(Urine routine (culture if needed) •Uncontrolled bowel bladder dysfunction (X-ray abdomen/Ultrasound).
结局指标
主要结局
To show significant improvement in symptoms post administration of Trancutaneous electrical Nerve Stimulation
时间窗: This will be assessed after 4 weeks of treatment
次要结局
- To provide that Trans-cutaneous Nerve Stimulation is devoid of side effects & provide a standard follow up period(It will be assessed after 3 months & 6 months post treatment)
研究者
Arunaa Sathyamurthy
Sri Ramachandra Institute of Higher Education and Research