Clinical trial NCT02492542: Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
Official title: Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: electrical stimulation
urinary incontinence
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Peking University First Hospital
name: Peking University Third Hospital
name: Beijing Hospital
name: Chinese PLA General Hospital
name: Peking University Cancer Hospital & Institute
name: Chinese Academy of Medical Sciences
name: Beijing Obstetrics and Gynecology Hospital
name: Beijing Chao Yang Hospital
First posted: 2015-07-08
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urination function recovery rate
timeFrame: From 14 days to 24 months after operation
Secondary outcomes:
measure: Number of participants with recovery of defecation function and urinary function after III hysterectomy
timeFrame: From 14 days to 24 months after operation
measure: Quality of life Questionnaire
timeFrame: From 14 days to 24 months after operation
measure: Overall Survival
timeFrame: From 14 days to 24 months after operation
measure: Disease-free survival
timeFrame: From 14 days to 24 months after operation
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital Ob and Gy
name: Wang J liu, Doctor
role: STUDY_CHAIR
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