A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
研究概览
简要总结
Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.
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
- •Female, >18 years of age, with the clinical diagnosis of overactive bladder.
- •Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
- •Baseline patient perception of bladder condition score of 2 or higher.
排除标准
- •Current or previous percutaneous 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
- •Abnormal sensory function of the lower limb
- •Metallic implant within the lower limb
研究组 & 干预措施
Sham
Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks
干预措施: Sham transcutaneous tibial nerve stimulation (Other)
Transcutaneous nerve stimulation
Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks
干预措施: Transcutaneous tibial nerve stimulation (Other)
结局指标
主要结局
Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
时间窗: 12 weeks
Patient percention 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
- Overactive Bladder Questionnaire Short Form (OAB-q SF)(12 weeks)
- Voiding Diary(12 weeks)
- 24hr Pad Weights(12 weeks)
- Physician Assessment of Treatment Benefit(12 weeks)
研究者
Blayne Welk
Assistant Professor of Surgery
Lawson Health Research Institute