Comparison of Parasacral Transcutaneous Electrical Stimulation With Transcutaneous Posterior Tibial Nerve Stimulation in Women With Overactive Bladder: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Efficacy of treatment in quality of life
研究概览
简要总结
Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.
Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.
详细描述
Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed
Main outcome: to measure changes in urinary urgency and quality of life.
Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.
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
- Single (Participant)
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
- •Diagnosis of overactive bladder with or without the presence of urinary incontinence.
- •Understand the instruments used in the research.
排除标准
- •Urinary tract infection
- •Neurological disease
- •Other previous treatment in the last four weeks
研究组 & 干预措施
Parasacral
Parasacral Transcutaneous Electrical Stimulation Group: participants in this group will receive two self-adhesive electrodes and will be instructed to position them in the sacral region. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks.
干预措施: Parasacral Transcutaneous Electrical Stimulation (Device)
Posterior Tibial Nerve
Transcutaneous Posterior Tibial Nerve Stimulation Group: participants in this group will receive a neoprene ankle brace that will be connected to the electrostimulator. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks.
干预措施: Transcutaneous Posterior Tibial Nerve Stimulation (Device)
结局指标
主要结局
Efficacy of treatment in quality of life
时间窗: six weeks
Application of the King's Health Questionnaire (KHQ). KHQ is an instrument for measuring quality of life in people diagnosed with urinary incontinence, consisting of 30 objective questions distributed in 9 domains. In each question, values are assigned according to the intensity of the patient's complaint (0 = not applicable, 1 = no; 2 = a little / sometimes, 3 = more or less / several times, 4 = a lot / always). The final score is calculated individually for each domain and ranges from 0 to 100, the highest score being related to a poorer quality of life.
次要结局
- Severity of overactive bladder symptoms(six weeks)
- Severity of urinary incontinence(six weeks)