跳至主要内容
临床试验/NCT01067261
NCT01067261已完成3 期

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

Copenhagen University Hospital at Herlev4 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2010年2月1日最近更新:
适应症

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

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

研究者

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

研究点 (4)

Loading locations...

相似试验