Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement
研究概览
简要总结
This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
详细描述
Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
- •Patients who consent to participate in the study
- •Patients on pharmacologic therapy at the time of recruitment can continue their treatment
排除标准
- •Pregnant patients
- •Patients with pacemakers of implantable defibrillators
- •Patients with neurogenic bladder
- •Patients who have received Botox or have an implant for sacral nerve stimulation
- •Patients with uncontrolled bleeding disorder
- •Patients with unhealed ulcers or with leg edema surrounding medial malleolus
结局指标
主要结局
Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement
时间窗: 12 weeks or last measurement
Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.
次要结局
- Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement(12 weeks or last measurement)
- Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement(12 weeks or last measurement)
- Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement(12 weeks or last measurement)
- Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement(12 weeks or last measurement)
研究者
Gnankang Sarah Napoe
Assistant Professor
University of Pittsburgh