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

Not Applicable

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Device: PHENIX USB 8.

• Registration Number: NCT02492542
• Lead Sponsor: Wang Jianliu

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric Stimulation Treatment	PHENIX USB 8.	Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing.

Primary Outcome Measures

Name	Time	Method
Urination function recovery rate	From 14 days to 24 months after operation

Secondary Outcome Measures

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