Pelvic Floor Rehabilitation for Gynecological Cancer Patients
2013年6月4日 更新者：Eun Joo Yang、Seoul National University Bundang Hospital
Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients
As cancer treatment improves, the cancer survivor's quality of life and level of function have gained increasing importance.
Pelvic floor function is directly affected by gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a patient's life.
PFD negatively affects health-related quality of life (HRQOL).
Evaluation of PFD provides information about the disease burden and treatment-related effects directly from the patient's perspective and informs clinical decision-making.
The pelvic floor musculature and sacral nerves are not easily accessible, and it is difficult to test them.
Several functional assessments have been used to evaluate pelvic floor dysfunction; however, reports on methodology are sparse, and consensus on their use is lacking.
Research on functional outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.
研究概览
详细说明
Patients with cervical or colorectal cancer who underwent surgery or radiotherapy are recruited for the study.
- PFM strength is measured using a perineometer (BioCon-200,McubeTechnologyCompany,Seoul,Korea). Vaginal pressure is measured using a vaginal silicon pressure sensor (cmH2O; sensitivity0.06kPa,sensitivity 5mV, threshold1.5V).
- The motor evoked potentials (MEPs) from the pelvic floor are obtained by sacral and transcranial magnetic stimulation using a Magstim 200 stimulator (Magstim Co., Whitland, Wales, UK). Patients are instructed to lie in the left lateral decubitus position,intra-anal sponge electrode (Dantec,Skovlund, Denmark)was lubricated and gently inserted into the anal canal.
- Monophasic single pulses of magnetic stimuli were delivered to the vertex corresponding to the primary motor center in the precentral gyrus using a double-cone coil(9902-00,Magstim). A figure-eight coil(9762-00,Magstim)was used to stimulate the dorsolateral area of the sacrum corresponding to the exit of the sacral cortical facilitation
- We measured the latency, amplitude, and excitability threshold(ET) of MEPs detected in pelvic floor muscles with and without facilitation. The excitability threshold at rest(RET) is defined as the lowest intensity that produced MEP responses of 100μV For optimal facilitation, we measure the latency of the MEPs with minimal contraction (10% of MVC) with RET intensity and amplitude with a moderate contraction
- Patient-reported HRQOL Quality of life General and condition-specific aspects of HRQOL were assessed using the EORTC QLQ-C30 questionnaires.
研究类型
介入性
注册 (预期的)
100
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seongnam、大韩民国、463-707
- 招聘中
- Seoul National University Bundang Hospital
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接触：
- Eun Joo Yang, MD. PhD
- 电话号码：82-787-7734
- 邮箱：graceloves@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women with gynecological cancer who had radical hysterectomy and pelvic lymph node dissection
Exclusion Criteria:
- infectious diseases of the urinary tract and vagina
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：pelvic floor exercise
pelvic floor rehabilitation program with neuromodulation
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pelvic floor rehabilitation program with neuromodulation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.
大体时间：1week after intervention
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We measure the amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus at the baseline and 1wk after intervention.
Then we compare the change of the amplitude (1 wk after intervention-baseline)between two groups.
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1week after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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pelvic floor muscle strength(mmHg)
大体时间：baseline, up to 1week after intervention
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We measure the pelvic floor muscle strength using perometer (mmHg)at baseline and 1 wk after intervention then compare the change of pelvic floor muscle strength(1wk after intervention-baseline) between two groups.
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baseline, up to 1week after intervention
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latency (ms) of MEP (motor evoked potential)
大体时间：baseline, up to 1week after intervention
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We measure the latency (ms) of MEP evoked by magnetic stimulation on the sacral plexus and compare the change of latency (1wk after intervention-baseline)between two groups
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baseline, up to 1week after intervention
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Functional score and symptom scale of QuEORTC QLQ-C-30,EORTC CX-24
大体时间：baseline, up to 1week after intervention
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We evaluate the functional score and symptom scale with EORTC QLQ-C30, EORTC QLQ-CX24 questionnaires and compare the change between two groups.
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baseline, up to 1week after intervention
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Total Bladder, bowel,sexual functional scores measured by the pelvic floor questionnaire
大体时间：baseline, up to 1week after intervention
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We evaluated the bladder, bowel, sexual functional scores with the interviewer-administered pelvic floor questionnaire at baseline and 1wk after intervention then compare the change of the scores between two groups
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baseline, up to 1week after intervention
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Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction measure with ultrasound
大体时间：baseline, up to 1week after intervention
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We measure the Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction using ultrasound with curved transducer (3.5-6 MHz)at baseline and 1 wk after intervention and compare the change between two groups
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baseline, up to 1week after intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Eun Joo Yang, MD, PhD、Seoul National University Bundang Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (预期的)
2014年7月1日
研究完成 (预期的)
2014年7月1日
研究注册日期
首次提交
2013年4月16日
首先提交符合 QC 标准的
2013年6月4日
首次发布 (估计)
2013年6月7日
研究记录更新
最后更新发布 (估计)
2013年6月7日
上次提交的符合 QC 标准的更新
2013年6月4日
最后验证
2013年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.