Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: PHENIX USB 8.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 G1-2. Patients agreed to the study, informed consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric Stimulation Treatment<br>Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing. | Device: PHENIX USB 8.<br>* Electrical stimulation program: frequency: 1/4/Hertz (HZ), pulse width: 270/230/270 μs, time: 30min. Electrode piece: 50*50mm sticky electrode plate. Position: an electrode piece is placed in the S3, and an electrode piece is placed in the bladder region.Current intensity adjusted according to the patient's tolerance, the maximum current intensity of the pain was not appropriate, generally not more than 100milliampere(mA).Devices PHENIX USB 8.<br>* Other names: Electric Stimulation Treatment;|
| No Intervention: control group<br>patients in this group only received routine clinical nursing without electric stimulation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urination function recovery rate |  | From 14 days to 24 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall Survival | The overall survival (OS) in cervical cancer patients after 3 years' III hysterectomy after comparison of pelvic floor rehabilitation therapy and control group | From 14 days to 24 months after operation | 
| Disease-free survival | Comparison of pelvic floor rehabilitation treatment group and control group of cervical cancer patients with type III hysterectomy 3 years disease-free survival (DFS) | From 14 days to 24 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, urinary incontinence