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临床试验/NCT01164280
NCT01164280已完成不适用

The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Improvement in voiding diary variables

研究概览

简要总结

Objectives: To evaluate the effect of pulse rate changes on the clinical response and stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.

Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation was kept off for 24 hours between consecutive test periods. The last 3 days of every test period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical response and pain symptoms were compared between the four pulse-rates using multivariate analysis.

Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD 12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic non-obstructive urinary retention. No significant difference was found regarding clinical outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the four pulse rates was significantly related to the occurrence of SNM-related pain. However, on individual basis, patients appear to benefit from changing the pulse rate concerning both treatment efficacy and stimulation related pain.

Conclusions: On group level, none of the four pulse rates in this study appears to have a significantly different effect on clinical outcome or SNM-related pain. However, a tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be useful.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention
  • Patients with suboptimal effect of their neurostimulator

排除标准

  • Patients with 100% effect of their neurostimulator

结局指标

主要结局

Improvement in voiding diary variables

次要结局

  • Improvement in subjective voiding symptoms

研究者

申办方类型
Other

研究点 (2)

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