Back to resultsEffect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
Primary Purpose
Lower Urinary Tract Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PHENIX USB 8.
Sponsored by
About this trial
This is an interventional supportive care trial for Lower Urinary Tract Symptoms focused on measuring electrical stimulation, urinary incontinence
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Electric Stimulation Treatment
control group
Arm Description
Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing.
patients in this group only received routine clinical nursing without electric stimulation
Outcomes
Primary Outcome Measures
Urination function recovery rate
Secondary Outcome Measures
Number of participants with recovery of defecation function and urinary function after III hysterectomy
Quality of life Questionnaire
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
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)
Full Information
NCT ID
NCT02492542
First Posted
June 25, 2015
Last Updated
March 13, 2018
Sponsor
Wang Jianliu
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT02492542
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wang Jianliu
Collaborators
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
electrical stimulation, urinary incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electric Stimulation Treatment
Arm Type
Experimental
Arm Description
Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing.
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients in this group only received routine clinical nursing without electric stimulation
Intervention Type
Device
Intervention Name(s)
PHENIX USB 8.
Other Intervention Name(s)
Electric Stimulation Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urination function recovery rate
Time Frame
From 14 days to 24 months after operation
Secondary Outcome Measure Information:
Title
Number of participants with recovery of defecation function and urinary function after III hysterectomy
Time Frame
From 14 days to 24 months after operation
Title
Quality of life Questionnaire
Time Frame
From 14 days to 24 months after operation
Title
Overall Survival
Description
The overall survival (OS) in cervical cancer patients after 3 years' III hysterectomy after comparison of pelvic floor rehabilitation therapy and control group
Time Frame
From 14 days to 24 months after operation
Title
Disease-free survival
Description
Comparison of pelvic floor rehabilitation treatment group and control group of cervical cancer patients with type III hysterectomy 3 years disease-free survival (DFS)
Time Frame
From 14 days to 24 months after operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang J liu, Doctor
Organizational Affiliation
Peking University People's Hospital Ob and Gy
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
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Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
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