Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Erectile function score by a validated symptom questionnaire (IIEF)
研究概览
简要总结
After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes side effects in the form of incontinence and erectile dysfunction.
It has previously been shown that one can stimulate the nerves of the pelvic floor by means of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study will examine the effect of TMNS in the preservation and restoration of urinary continence and erectile function and in the treatment of urinary incontinence and erectile dysfunction in conjunction with radical prostatectomy.
The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the penis which may improve their function and there by prevent or minimize the occurrence of incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to eliminate these symptoms once they have occurred. It is possible that TMNS will also directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of this tissue. In case the improved nerve function is not great enough to secure satisfactory erectile function in itself it may still improve the effect of PDE-5-inhibitors.
In pilot studies TMNS has already shown an effect in the treatment of urinary continence.
In this study the patients will be randomized to either TMNS treatment or no TMNS treatment. In both groups the patients will participate in a pelvic floor muscle training program. In the group receiving active treatment this will be supplemented by TMNS treatment. The two groups will be evaluated and compared with regard to erectile function time to continence after surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo nerve sparing radical prostatectomy
- •Continent before surgery
- •A minimum score on the IIEF-questionnaire of 18
- •Sexually active
排除标准
- •Treatment with nitrates
- •Treatment with α-blockers
- •Serious cardiovascular disease
- •Severely reduced liver function,
- •Retinitis pigmentosa,
- •Non-arteritic ischemic optic neuropathy (NAION)
- •Previous vascular infarction of the eye
结局指标
主要结局
Erectile function score by a validated symptom questionnaire (IIEF)
时间窗: At 3 months, 6 months and 1 year
Time to continence after surgery
时间窗: At 3 months, 6 months and 1 year
次要结局
未报告次要终点
