Radiofrequency as the New Opportunity in Treating Overactive Bladder and Urgent Urinary Incontinence - a Prospective Randomized Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- changed symptoms specific for OAB
研究概览
简要总结
Until now, OAB with or without UUI has been treated mainly in two ways: with behavioral methods and/or patient education or using antimuscarinic drugs and/or beta 3 adrenergic receptor agonists. Unfortunately, the drugs might cause side effects in some women or were insufficiently effective, so the patients abandoned them.
Methods In prospective, randomized, placebo controlled study, 80 women were enrolled, using radiofrequency in treating OAB and UUI. Based on ICIQ-OAB, ICIQ-OAB QoL, and ICIQ-FLUTSsex questionnaires, severity of OAB symptoms, QoL and detailed evaluation of female sexual matters associated with their lower urinary tract symptoms. RF was applied 4 times for 20 minutes, once a week. Two week after the completion of the treatment,as well as 3, 6 and 12 months, the level of OAB and UUI was reassessed and processed it statistically and evaluated the treatment effect.
详细描述
Criteria for inclusion in the study Women who have clear signs of OAB was included in the study. Also, those women who did not use drugs for the treatment of OAB (antimuscarinics/beta-3 agonists), were included.
Those women who have taken drugs for the treatment of OAB in the past, but stopped (side effects, ineffectiveness) and at least 3 months have passed since the last treatment, were also included in the study.
Exclusion criteria from the study Inserted heart pacemaker, unexplained bleeding from the vagina, inflammation of the vagina and/or uterus or uterine appendages. Bacterial or viral infection, impaired immune system, sclerodermia, radiation treatment, burns in the treatment area. Women with stress urinary incontinence (SUI) or mixed urinary incontinence were not included in the study.
Radiofrequency in the treatment of urinary incontinence
In the study, the radiofrequency device Capenergy model C 100 with an upgrade to the urogynecological model C 500, was used. This device has a 1-channel capacitive and resistive probe for individual use. The mechanism of action is electrotherapy with the help of high-frequency electricity (TECAR).
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •clear signs of OAB
- •did not use drugs for the treatment of OAB (antimuscarinics/beta-3 agonists)
- •women who have taken drugs for the treatment of OAB in the past, but stopped at least 3 months prior the entering the study.
排除标准
- •Inserted heart pacemaker,
- •unexplained bleeding from the vagina,
- •inflammation of the vagina and/or uterus or uterine appendages.
- •Bacterial or viral infection,
- •weakened immune system,
- •sclerodermia,
- •radiation treatment,
- •burns in the treatment area,
- •stress urinary incontinence (SUI) or mixed urinary incontinence
研究组 & 干预措施
study group
The patients were lying in the lithotomy position with the streTched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe). A capacitive probe in the "free treatment" / "power control" program was used, where high frequency electricity was released to the bladder for 20 minutes with a frequency of 1.0 MHz and energy to maximum 410 C. Initialy, maximum energy of 75% and a frequency of 0.8 MHz was applied, which was reduced depending on the heat that was pleasant for the patient. Then, the power was reduced to 50% and increased the frequency to 1.0 MHz, which also meant moderate energy absorption. The procedure with this energy was continued until the end, and the patients absorbed 18-19 kJ of energy in average.
干预措施: study group (Device)
placebo group
The patients were lying in the lithotomy position with the streched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe) . A capacitive probe in the "free treatment" / "power control" program was used, with NO electricity was released to the bladder for 20 minutes
干预措施: study group (Device)
placebo group
The patients were lying in the lithotomy position with the streched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe) . A capacitive probe in the "free treatment" / "power control" program was used, with NO electricity was released to the bladder for 20 minutes
干预措施: placebo (sham control) (Device)
结局指标
主要结局
changed symptoms specific for OAB
时间窗: 2 weeks, 3 months, 6 months, 12 months
frequency of urination, nocturia, urgency, incontinence
次要结局
未报告次要终点