NCT04506658Unknown不适用
Efficiency and Safety of High-frequency Radio Wave Electrotherapy With a Radio Frequency of 448 kHz in the Treatment of Patients With Organic Erectile Dysfunction.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A statistically significant increase in the number of points IIEF-5
研究概览
简要总结
Efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of 448 kHz in the treatment of patients with organic erectile dysfunction. Sham comparator, parallel study including both the main and control group to demonstrate the efficiency of the device to treat erectile dysfunction.
详细描述
The objectives of this study are:
- To evaluate the effectiveness of the course treatment with the apparatus for continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in patients with organic erectile dysfunction.
- Assess the safety and tolerability of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in patients with organic erectile dysfunction.
- To evaluate the duration of the effect of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz.
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 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 79 years;
- •The diagnosis is confirmed by assessing the functional criteria of arterial factors of panel hemodynamics (dopplerography);
- •The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire
- •Patients with organic erectile dysfunction lasting at least 6 months.
- •Patients with IIEF from 6 to 22 points.
- •Patients with a permanent sexual partner for more than 3 months;
- •Sexually Active Patients.
- •Non-inclusion criteria:
- •The use of other treatments for erectile dysfunction
- •Age under 18 and over 79 years old;
- •Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease);
- •The presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia);
- •Running coagulation disorders;
- •The presence of tumors in the area of electrotherapy;
- •The presence of aneurysms in the propagation of radio frequency waves;
- •Angina pectoris;
- •Myocardial infarction, stroke, life-threatening arrhythmias;
- •Thrombosis, thromboembolic disease;
- •Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.);
- •The patient has a mental illness that does not allow an assessment of the effectiveness of therapy; history of alcoholism and drug addiction;
- •Active tuberculosis, chronic somatic diseases in the acute stage;
- •Condition after coronary artery bypass grafting (CABG);
- •Patient's involvement in another clinical trial in the last 3 months;
排除标准
- •Serious unwanted phenomenons associated with exposure to the apparatus.
- •Incorrect inclusion in the study.
- •A marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease.
- •The patient's appearance of non-inclusion criteria during the study.
- •Serious deviation from the protocol.
- •The desire of the patient or his legal representative.
研究组 & 干预措施
Intervention group
Experimental
干预措施: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. (Device)
Control group
Sham Comparator
干预措施: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. (Device)
结局指标
主要结局
A statistically significant increase in the number of points IIEF-5
时间窗: Through study completion, an average of 3 months after first procedure
IIEF-5
次要结局
- A statistically significant increase in penile blood flow.(Through study completion, an average of 3 months after first procedure)
- Statistically significant increase in SEP scores (Sexual Encounter Profile)(Through study completion, an average of 3 months after first procedure)
研究者
Dmitry Enikeev, MD, PhD
Director for Research
I.M. Sechenov First Moscow State Medical University
研究点 (1)
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