A Prospective Multicenter Randomized Blind Placebo-controlled Trial "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change baseline of micturition episodes per day
研究概览
简要总结
The main hypothesis of this study is that magnetic neuromodulation can be used to correct bladder overactivity. The investigators assume that the transvertebral magnetic stimulation can improve both the subjective state of patients evaluated through questionnaires and objective parameters evaluated through invasive and non-invasive urodynamic studies. This study will compare two protocols for magnetic stimulation of the sacral spine roots (S2-S3 segments). The investigators propose to find out the dependence of the therapeutic effect on the frequency of stimulation, the frequency of procedures and the duration of the treatment course.
详细描述
The aim of the study is to test the hypothesis that the use of magnetic stimulation of the sacral spine roots (S2 - S3) in patients with idiopathic overactive bladder (OAB) will help reduce the clinical and urodynamic manifestations of bladder overactivity.
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)
盲法说明
The hidden distribution of patients will be made with using sequentially numbered sealed opaque envelopes containing the patient's digital code. The randomization code will be recorded in the participant's notes, the patient report form. Then the "sent out" code will be provided to the doctor to prepare a stimulation or placebo.Blinding during the study will be achieved by using a specialized "placebo" function built into the magnetic stimulator "Neuro-MS/d Therapeutic". When using this option, the patient will hear the characteristic sound of the device running, but full pulse stimulation will not be performed. Patients will be deprived of information about the treatment received (stimulation/placebo).
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Signed informed consent;
- •The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence;
- •The presence of detrusor overactivity patterns based on the results of the urodynamic study (UDI)
排除标准
- •The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant).
- •Convulsive attacks in the anamnesis;
- •Taking medications that may trigger the risk of seizures;
- •Pregnancy or suspicion on it;
- •The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.)
- •Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
- •Pelvic organ prolapse (II-IV stages according to the POP-Q system)
- •The presence of urinary tract infection
- •The presence of tumors of the pelvic organs
结局指标
主要结局
Change baseline of micturition episodes per day
时间窗: 4, 12, 24, 48 weeks
Patients should document how many times they go to the restroom during the day and at night, as well as the loss of urine in stressful situations (coughing, sneezing, laughter, squatting, weightlifting, walking, running), changing liner or absorbent and episodes of urgency and urgency-incontinence. The journal shall be held for a consecutive period of 24 hours, for a minimum of three consecutive days.
次要结局
- OAB-Q SF Change Score(Baseline, 4, 12, 24, 48 weeks)
- PGI-I Change Score(Baseline, 4, 12, 24, 48 weeks)