The Effects of Transcutaneous Tibial Nerve Stimulation in Sympathetic and Parasympathetic System in Women With Overactive Bladder: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Parasympathetic and sympathetic system values obtained from heart rate variability (HRV) after TENS application
研究概览
简要总结
The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical syndrome characterized by urgency with or without urge incontinence , usually accompanied by frequency and nocturia , since in the absence of proven infection or other pathology related . The negative impact on quality of life of patients with OAB is already known. The etiology and pathophysiology of OAB are not completely understood. However, studies indicate an alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way . However, no studies in the literature evaluating the effect of electroconvulsive therapy on the mechanisms involved in sympathetic and parasympathetic modulation in these women . The objective of this study is to investigate the effects of TENS on the sympathetic and parasympathetic system in women with OAB . This is a randomized, double -blind , which will be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2 groups : TENS group and placebo group. Interventions take place in one day assessment of the sympathetic and parasympathetic nervous system are performed . After collecting the data will be analyzed in accordance with the statistical analysis.
详细描述
Hypothesis True:Electrical stimulation of the tibial nerve (TENS) decreases the activity of the parasympathetic nervous system and increases the activity of the sympathetic nervous system in women with overactive bladder.
Null Hypothesis: The electrical stimulation of the tibial nerve (TENS) does not decrease the activity of the parasympathetic nervous system and does not increase the activity of the sympathetic nervous system in women with overactive bladder.
Alternative Hypothesis: The electrical stimulation of the tibial nerve (TENS) increases the activity of the parasympathetic nervous system and decreases the activity of the sympathetic nervous system in women with overactive bladder.
Intervention Programmes
The randomization technique is carried out through sequential numbers kept in opaque envelopes, not translucent and closed. This takes into account that a major goal of randomization is to prevent the researcher to identify which intervention will be performed in each patient. The generation of sequence numbers will be made by researcher "blind" the study after patient selection criteria for inclusion and exclusion. The sequence of numbers to be used for randomization will be kept confidential until the exact moment of the beginning of the intervention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 60 years;
- •Clinical Diagnosis of Overactive Bladder Syndrome non neurogenic type;
- •Score Questionnaire OAB-V8, sum equal to or greater than eight (8);
- •Calendar indicating voiding more than 8 micturitions in 24 hours;
- •Complaints of urinary urgency.
排除标准
- •With a diagnosis of lower urinary tract;
- •Signs of leukorrhea / diagnosis of vaginitis;
- •Pregnant women;
- •Diagnosed with bladder cancer and other pelvic organs;
- •With a history of pelvic radiotherapy;
- •With change in the sensitivity of the pelvis and lower limbs region;
- •With Diabetes Mellitus;
- •With known neurologic diseases;
- •Patients on medications that may affect the autonomic nervous system, including anticholinergics, alpha-adrenergic antagonists, tricyclic antidepressants, serotonin, antimuscarinic, beta-receptor agonists or antagonists and antihypertensive agents;
- •Use of cardiac pacemakers.
结局指标
主要结局
Parasympathetic and sympathetic system values obtained from heart rate variability (HRV) after TENS application
时间窗: 50 minutes
For the analysis of HRV time, series of RR intervals obtained from continuous ECG signal recorded (sampling frequency = 1 kHz) for the MP150 system (Biopac, California, USA) will be interpolated and decimated to obtain equally spaced in time series and then subjected to a Fast Fourier Transform (FFT) algorithm developed using a Matlab (Matlab 6.0, Mathworks Inc., USA) language. The spectral power is calculated by integrating each frequency band of interest. The time series of RR will be analyzed in the time domain and the frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD).
次要结局
未报告次要终点
研究者
Luís Henrique Telles da Rosa
Clinical professor and vice-rector
Federal University of Health Science of Porto Alegre