A Prospective Randomized Trial "The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- IPSS change score
研究概览
简要总结
The main hypothesis of this study is that peripheral magnetic neuromodulation can correct the symptoms of lower urinary tract in men. We assume that under the influence of t peripheral magnetic stimulation, both the subjective state of patients assessed by standardized questionnaires and a urination diary, as well as the objective parameters, assessed by non-invasive urodynamic studies, will be improved. This study will use standard protocols built into the BTL Emsella magnetic stimulator.
详细描述
The aim of the study is to test the hypothesis that the use of the peripheral magnetic stimulation in men with lower urinary tract symptoms will help to reduce subjective and objective clinical symptoms and improve the quality of life of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Signed informed consent;
- •The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.
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;
- •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.)
- •The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
- •The postvoid residual volume (more than 50 ml);
- •The concentration of prostate specific antigen (PSA) in the blood is more than 4.0 ng / ml;
- •The presence of urinary tract infection;
- •A history of cancer of the pelvic floor organs;
研究组 & 干预措施
Experimental group
10 sessions of non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation".
干预措施: Peripheral magnetic neuromodulation (Other)
Control group
one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme
干预措施: Taking drug Tamsulosin (Drug)
结局指标
主要结局
IPSS change score
时间窗: Baseline, 4, 12, 24, 48 weeks
The IPSS questionnaire evaluates the impact of lower urinary tract symptoms on the patient's quality of life. It consists of 8 questions. Questionts evaluates whether the patient has symptoms of incomplete emptying of the bladder and ranges from 0 to 5 points. The increase in scores is directly proportional to the increase in symptoms.
Change baseline of micturition episodes per day
时间窗: Baseline, 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
- Change baseline of micturition episodes per day(Baseline, 4, 12, 24, 48 weeks)