Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 主要终点
- Urination function recovery rate
研究概览
简要总结
The purpose of this study is to investigate the effect of electric stimulation on the pelvic floor function in cervical cancer patients with type III hysterectomy.
详细描述
This is a prospective, multi center, open, randomized, controlled clinical trial. All cervical carcinoma patients who undergo type III hysterectomy in the hospitals involved in this study were recruited. 5-7 days postoperative, those who meet the inclusion criteria and without the exclusion criteria and sign the consent were randomized grouped of intervention and control objective by 1:1. At the same time, according to the research hospital, menopausal status (menopause vs menopause) and surgery approach (laparoscopic vs open)，they were further stratified randomly. Patients in the intervention group received electrical stimulation treatment based on conventional clinical nursing, while patients in control group only receive routine clinical care. Except for the treatment of electrical stimulation, other research procedures is the same in the two groups. The recovery rate of urination function, pelvic floor function and life quality of the two group is compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as cervical squamous cell carcinoma on Ⅰa2, Ib1 or Ⅱa1 stage
- •Type III hysterectomy
- •There are pathological results showing that cancer resection clean and no distant metastasis,Specifically as follows:Lymph nodes(-);cancer foci invasion depth <1/2;Lymphatic space(-);Vaginal stump(-);differentiation G1-
- •Patients agreed to the study, informed consent
排除标准
- •Radiotherapy and chemotherapy before surgery
- •Reserved nerve in the surgery
- •Urinary system damage
- •POP(Pelvic Organ Prolapse stage)>II stage before surgery
- •Moderate above stress urinary incontinence(SUI) before surgery(1 hours urine pad test>=10g)
- •Urinary retention before surgery
- •Severe constipation or difficult defecation before surgery
- •There are uncontrolled epilepsy, central nervous system disease or mental disorder history in patients.The clinical severity of these diseases Influence clinical research compliance,judging by the researcher.
研究组 & 干预措施
Electric Stimulation Treatment
Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing.
干预措施: PHENIX USB 8. (Device)
control group
patients in this group only received routine clinical nursing without electric stimulation
结局指标
主要结局
Urination function recovery rate
时间窗: From 14 days to 24 months after operation
次要结局
- Number of participants with recovery of defecation function and urinary function after III hysterectomy(From 14 days to 24 months after operation)
- Quality of life Questionnaire(From 14 days to 24 months after operation)
- Disease-free survival(From 14 days to 24 months after operation)
- Overall Survival(From 14 days to 24 months after operation)
研究者
Wang Jianliu
Peking University People's Hospital Ob and Gy
Peking University People's Hospital