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

Wang Jianliu

Status

Unknown

Conditions

Lower Urinary Tract Symptoms

Treatments

Device: PHENIX USB 8.

Study type

Interventional

Funder types

Other

Identifiers

NCT02492542

D151100001915003

Details and patient eligibility

About

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.

Full 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.

Enrollment

208 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.