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临床试验/NCT00695058
NCT00695058撤回3 期

Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence

Copenhagen University Hospital at Herlev6 个研究点 分布在 2 个国家开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
3 期
状态
撤回
发起方
试验地点
6
主要终点
Diaper test - weight (grams); Micturition diary - The number of involuntary incontinence and normal micturition episodes; Amplitude of vibration (mm) and pressure (cm H2O) in the external sphincter of the urethra

研究概览

简要总结

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that TMNS in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome.

The present study aims to treat urinary incontinence and includes 3 groups of patients with 40 patients in each group: Women suffering from urinary stress incontinence, women suffering from urge incontinence and men suffering from urinary incontinence after a prostatectomy. A medical vibrator is used and in each group the subjects will be randomized to active treatment or placebo treatment.

In women the stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. In men the vibration parameter/location will be determined by the results of a pressure profile study also included. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If we are able to demonstrate a significant reduction in the incontinence symptoms in the subjects we asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women suffering from stress incontinence
  • Women suffering from overactive bladder syndrome
  • Men who are still incontinent at a minimum of one year after a radical prostatectomy

排除标准

  • Pregnant and nursing women will not be included in the study

结局指标

主要结局

Diaper test - weight (grams); Micturition diary - The number of involuntary incontinence and normal micturition episodes; Amplitude of vibration (mm) and pressure (cm H2O) in the external sphincter of the urethra

时间窗: Before treatment, after treatment and at follow up

次要结局

  • Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms(before treatment, after treatment and at follow up)

研究者

发起方
Copenhagen University Hospital at Herlev
申办方类型
Other

研究点 (6)

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