Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Overactive Bladder Questionnaire (OAB-q)
研究概览
简要总结
This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 6 episodes urgency incontinence on 3-day voiding diary
- •Duration of symptoms ≥ 3 months
- •Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
- •No known neurologic disease
- •Ability to complete home sessions and clinic follow up
- •Ability to complete voiding diaries
- •Internet access and proficiency
- •English or Spanish-speaking
排除标准
- •Known or suspected urinary retention
- •Symptomatic urinary tract infection unresolved at the time of randomization
- •Recurrent urinary tract infection (≥ 3/12 months)
- •Bladder pain syndrome
- •Known or suspected advanced (stage III or IV) pelvic organ prolapse
- •Neurogenic bladder
- •Current or prior bladder malignancy
- •Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation
- •Pacemaker or other implantable device
- •Disease affecting lower extremities
- •Bilateral metallic lower limb implant
- •Incarceration
结局指标
主要结局
Overactive Bladder Questionnaire (OAB-q)
时间窗: 12 weeks
To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group.
次要结局
- Voiding diary(12 weeks)