Does Bladder Training (BT) Improve the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in Women With Refractory Overactive Bladder (OAB) - A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Primary outcome will reduction in number of urgency episodes (bladder diary)
研究概览
简要总结
Overactive Bladder (OAB) is a chronic condition defined as urgency with or without incontinence usually associated with frequency and nocturia. It is a common condition affecting 15-45% of adults and constitutes a significant proportion of patients attending urogynaecology clinics. OAB is known to have a significant impact on the physical, social and emotional quality of life and sexual function in women. The treatment of OAB is initially conservative with bladder training followed by pharmacotherapy.
Evidence from a recent Cochrane review on treatment of OAB suggests that the efficacy of anticholinergics in treatment of OAB is enhanced when combined with BT. Women who fail to improve with these initial measures are offered Intravesical Botox or neuromodulation in the form of Percutaneous Tibial Nerve Stimulation (PTNS) or Sacral Nerve Stimulation (SNS).
PTNS has also been shown to more effective than pharmacotherapy with anticholinergics. In 2010 National Institute of Clinical Excellences (NICE) issued guidance stating '"PTNS for OAB demonstrates effectiveness without major safety concerns"
We hypothesise that the outcome of PTNS will improve if the PTNS sessions are combined with bladder training (BT).
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women with refractory OAB who are offered PTNS as a treatment option
排除标准
- •Who cannot give informed consent.
- •Women in whom PTNS is contraindicated. This includes women who have:
- •Gross leg oedema A pacemaker
结局指标
主要结局
Primary outcome will reduction in number of urgency episodes (bladder diary)
时间窗: 3 months
All patients complete a bladder diary (A record of fluid intake, voided volumes, urgency and incontinence episodes for 3 days) prior to commencement and at 3 months.
次要结局
- urgency incontinence episodes(24 months)
- increase in mean void volume(3 months)
- improvement in quality of life and urgency scores(24 months)
- reduction in frequency(24 months)