Lower Urinary Tract Symptoms
Conditions
Keywords
electrical stimulation, urinary incontinence
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.
Interventions
DEVICEPHENIX USB 8.
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.
Sponsors
Peking University
Peking University First Hospital
Peking University Third Hospital
Beijing Hospital
Chinese PLA General Hospital
Peking University Cancer Hospital & Institute
Chinese Academy of Medical Sciences
Beijing Obstetrics and Gynecology Hospital
Beijing Chao Yang Hospital
Wang Jianliu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urination function recovery rate | From 14 days to 24 months after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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) |
Outcome results
None listed