A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Patient Perception of Bladder Condition Questionnaire
研究概览
简要总结
Neurogenic bladder patients may have symptoms of urinary frequency, urgency, urgency incontinence and voiding symptoms due to bladder dysfunction arising from their underlying neurologic condition. Current treatment options are effective for some patients, however many patients are not optimally managed due to modest efficacy or significant side effects. Second line therapies include intravesical onabotulinum toxin, however it is associated with a risk of urinary retention, and patients with neurologic disorders often are unable to perform self catheterize due to physical limitations. Sacral neuromodulation is associated with an undesirably high cost and potential complications in this population. The use of transcutaneous tibial nerve stimulation is an alternative form of neuromodulation, and it may have some potential benefits over percutaneous tibial nerve stimulation. While some preliminary studies have suggested it may be effective, there are no high quality randomized trials. This proposal is a 3 month, randomized, sham-controlled, clinical trial to evaluate the short term clinical efficacy of at home transcutaneous tibial nerve stimulation. Valid and reliable patient reported outcome measures, and objective measures of incontinence have been included as outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age, with a clinical condition associated with neurogenic bladder dysfunction (multiple sclerosis, Parkinson's disease, stroke, dementia, cerebral palsy, spinal cord injury)(27).
- •Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms.
排除标准
- •Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy
- •Stress predominant urinary incontinence
- •Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron)
- •Intravesical botulinum toxin use within the last 1 year
- •Implanted pacemaker or defibrillator
- •History of epilepsy
- •Unable or unwilling to commit to study treatment schedule
- •Pregnant, or possible pregnancy planned for the duration of the study period
- •Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
- •Documented allergy to patch electrodes or their adhesive
- •Metallic implant within the lower limb
结局指标
主要结局
Patient Perception of Bladder Condition Questionnaire
时间窗: 3 months
Patient perception of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes.
次要结局
- Neurogenic Bladder Symptom Score (NBSS) Questionnaire(3 months)
- 24hr Incontinence Pad Weights(3 months)
- Physician Assessment of Patient Benefit (Global Response Scale)(3 months)
- Qualiveen-Short Form Questionnaire(3 months)
- 3-day Voiding Diary(3 months)