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A Randomized Controlled Trial Of Low Frequency Electrical Stimulation Combined With Biofeedback In The Treatment Of Pelvic Floor Dysfunction After Cervical Cancer Surgery

Posted on:2018-12-16Degree:MasterType:Thesis
Country:ChinaCandidate:Y SuFull Text:PDF
GTID:2334330515473356Subject:Obstetrics and gynecology
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Cervical cancer as the female reproductive system is one of the most common known common malignant tumors,more and more people pay attention.In China,with the popularity of cervical cancer screening,more and more early and mid-cervical cancer to be found,and was young development trend.Although in recent years since the development of domestic and foreign,early cervical cancer has narrowed the scope of surgery,but extensive hysterectomy + pelvic/abdominal primary lymphadenectomy(Piver ?)is still commonly used surgery.Because of its large scope of surgery,time-consuming,pelvic floor ligament,blood vessels and nerves are damaged or removed to varying degrees,resulting in some patients with postoperative pelvic floor dysfunction(PFD)high incidence.Mainly for urinary retention,urinary system infection,defecation disorders,and sexual dysfunction.And urinary fistula,pelvic infection,lymphatic cysts,is rare.Cervical cancer postoperative pelvic floor dysfunction is high,seriously affecting people's quality of life,how to improve the quality of life of patients with cervical cancer after surgery has become an urgent need to solve the problem.Studies have shown that changes in the electrophysiological function of the pelvic floor and PFD have a considerable correlation between the pelvic electrophysiology changes earlier than the emergence of PFD.Therefore,the corresponding damage of pelvic floor tissue can be detected by early electrophysiological examination;electrophysiological treatment of pelvic floor can prevent the occurrence of pelvic floor dysfunction and can be treated.Studies have shown that electrical stimulation combined with biofeedback treatment of pelvic floor dysfunction is better than a single treatment program.This article will focus on low frequency electrical stimulation combined with biofeedback treatment of cervical cancer after pelvic floor dysfunction clinical management and efficacy.PurposeIn this study,we conducted a prospective randomized controlled trial to analyze the effect of low frequency electrical stimulation combined with biofeedback therapy on postoperative pelvic floor dysfunction in patients with early and middle stage cervical cancer and the impact on quality of life.Materials and methods1 the object of studyFrom January 2015 to January 2016 in zhengzhou university people's hospital of obstetrics and gynecology treated all the extensive hysterectomy resection + pelvic lymph node cleaning and confirmed by pathological results for malignant tumor,75 cases of cervical cancer patients.Inclusion criteria:(1)age is less than 60;(2)the clinical stages of cervical cancer are ?a2-?a2;Exclusion criteria:(1)preoperative and postoperative chemotherapies;(2)the preoperative pelvic organ organ prolapse is greater than the age of ?;(3)age or 60;(4)the retention of urine before surgery;(5)those who are in trouble before the operation;(6)the incontinence of the incontinence before the operation;(7)the disease(8)that is affected by the follow-up is not determined by the effect of the effect or the effect of the data;Withdrawal criteria:(1)the researchers considered the need to terminate the trial from a medical point of view;(2)the patient himself asked to stop the experiment;(3)serious complications or adverse reactions occurred during the trial period.Research method2.1 grouping:The randomized digital table method would meet the criteria for 75 cases of cervical cancer in two groups,38 in the experimental group,5 invisitation,2 in his department,and 1 refusal follow-up.In the control group 37 people,3 cases were lost,4 cases were transferred to his medical treatment,and when the case was collected,the integrity of the follow-up data was eliminated.Pelvic floor therapy group:30,age 36 to 59 years old,average age(48.93 + +7.21).For the group:30,age 37 to 59,average age(50.93 + + 4.01).Specific methods:Both groups underwent extensive hysterectomy and pelvic lymph node cleaning.2.2.1 postoperative early intervention plan:pelvic floor treatment group after 5 days give PHENIX neuromuscular therapy apparatus 8-PLUS electrical stimulation treatment of 2 days,urinary retention plan is:35 hz frequency,pulse width 200 mu s,2 times/day,time for 20 minutes.The electrodes are placed in an area of S3 and another in the bladder.The electrode slice is selected with 50*50mm adhesive electrodes.After 7 days,the urine was removed from the urine,and the residual urine was less than 100 ml,and the electrical stimulation was stopped.>100 ml as urinary retention,residual urine into urinary canal again,continue to 8-PLUS electrical stimulation therapy,2 times a day,7 days,14 days out again urine tube,residual urine,and residual urine acuity of up to 100 ml,no longer give 8-PLUS electrical stimulation therapy,according to the clinical routine treatment.In the control group,no special treatment was made for the residual urine of the urine after 7 days.If residual urine is greater than 100ml of retained urine,the residual urine will be removed after 7 days,and if residual urine is greater than 100ml of retained urine,it will be treated as normal.2.2.2 mid-term postoperative intervention plan:pelvic floor treatment group give basin of abdominal postoperative 9 week electrophysiological treatment:PHENIX neuromuscular therapy apparatus 8-plus pot belly lower limb vascular smooth muscle electrical stimulation(circulation)6 weeks.The stimulus program was activated by blood power,2 times/week,and the program was:frequency 4Hz,20min;Electrode slice:50*90mm adhesive electrodes,two groups(4)Position:one group is placed in the right and left instep,the other one is placed on the right side of the total abdominal vein,and the other is placed in the same position on the corresponding back.Postoperative 13 weeks after operation of the pelvic floor,the stimulation and biofeedback 6 weeks,1 week 2,12 times,30min.Electrode position:the A1 channel pelvic floor muscles treatment head is placed in the vagina,the A2 channel electrode is placed in the abdomen,and the geodesic marker is placed in the iliac crest.Biofeedback:the U8 built-in biofeedback training module,perineum-abdominal coordination and contraction.Electrode:the first 50*50mm viscous electrode film of the pelvic floor muscles of sugiyama.Position:the A1 channel pelvic floor muscles treatment head is placed in the vagina,the A2 channel electrode is placed in the abdomen,and the geodesic marker is placed in the iliac crest.In the control group,there was no special intervention.Specific monitoring indicators2.3.1 subjective parts:function of pelvic floor dysfunction questionnaire of quality of life questionnaire(PFDI-20)PFDI-20 is specially designed for female pelvic diseases,with a total of 20 questions,respectively from the urination,defecation symptoms and pelvic organ prolapse symptoms three parts understanding of pelvic floor functional disorder of patients quality of life and the influence of the evaluation of the severity of the subjective symptoms.The overall rating was 0-300,and the higher the score,the greater the impact on life.Pelvic floor disorders impact questionnaire(PFIQ-7),respectively,from the bladder,bowel or vaginal affect daily life three aspects,calculate the total score,the higher the score,on behalf of the greater the influence of life;Sexual function quality questionnaire,the higher the score the better the quality of sex.2.3.2 objective parts:two groups of patients were compared with urinary retention.Residual urine,100ml,urine retention.2.3.3 part objective:pulling the urine tube time and hospitalization time:general remoal of ureter in postoperative uterine cervix cancer time is 7 to 14 days,the longer the length of hospital stay,the corresponding hospitalization cost is higher.2.3.4 part objective:pelvic floor functional check:mainly including free urine flow rate measurement(maximum urinary flow rate,average urine flow rate,tmax,micturition time,residual urine),pelvic floor electrical physiological function(type I muscle fibers strength,type ? muscle fibers fatigue,class II muscle fiber strength,?class of muscle fatigue,muscle potential),pelvic floor urinary continence function(A3 feedback),pelvic floor function check(sexual reflex).Measurement of free urinary flow rate:maximum urinary flow rate Qmax,average urinary flow rate Qave,urination time,peak time,and residual urine measurement.The normal range is Qmax,which is greater than 20ml/s,Qave is greater than 20ml/s,and the amount of urination is capped at 100ml of urine,and the amount of urine is up to a maximum of 23 seconds,and the residual urine is normal<100ml.2.3.4.2 Pelvic electrophysiological function:Class I muscle fiber strength is divided into 0-5 level,the patient's vaginal muscle contraction duration reached its maximum value of 40%.Continuous 0 seconds for the 0 level,for 1 second for the 1,2 seconds for the 2,3 seconds for the 3,4 seconds for the 4,5 seconds for the 5;II muscle fiber strength,the patient with the greatest effort and Speed uniform contraction and relaxation of the vagina,to achieve the maximum contraction force 1 for 1,2 for the 2,3 times for the 3,4 times for the 4,5 times for the 5 level.?,?muscle fiber muscle strength>3 level is normal.The percentage of the descending ratio between the highest points from the highest end to the 6s end is fatigue,normal 0%,and negative values are abnormal.The normal value of myasthenia is 20-30? V,and the decrease in myoelectric potential indicates a decrease in the number of muscle fibers involved in pelvic floor contraction.2.3.4.3 The function of pelvic floor control is A3,which mainly reflects abnormal urination.2.3.4.4 The pelvic floor function examination is mainly the pelvic floor function reflex,the sexual function reflex mainly manifests as normal and abnormal.2.4 equipmentPHENIX neuromuscular therapy instrument 8-plusNerve repair instrument U8Pelvic floor muscle therapy headColor doppler ultrasonic examination instrument France VIVALTIS co.,LTDFrance VIVALTIS co.,LTD.Is an agent for the guangzhou shanshan companyFrance VIVALTIS co.,LTD.Is an agent for the guangzhou shanshan companyGermany's Siemens3 quality control3.1 The document management method is used to ensure the authenticity and homogeneity of the data.Writing flowcharts,writing standardized operation processes,designing uniform questionnaires,using standardized scales;3.2A11 patients have extensive hysterectomy and pelvic lymphadenectomy by my senior physicians.3.3 patients used the same type of PHENIX neuromuscular therapy instrument 8-plus and nerve repair instrument U8,both of which are produced by guangzhou shanshan.3.4 surgical personnel,data recorder,PHENIX neuromuscular therapy instrument 8-plus and neurorepair instrument U8 operation physician,training,unified standards;The blind method of the surgical personnel and the data recorder;3.6 is collected and recorded by a third party.Medical ethicsThe study was approved by the medical ethics committee of the hospital,with each patient signing informed consent forms.Five statistical methodsEpidata3.0 is adopted to establish the database,by two independent input,a trained researchers used after verification SAS9.4 statistical analysis software for processing,measurement data using mean +/-standard deviation(x + S)concentration and discrete trend,using t test or analysis of variance difference inspection;The counting data is using the chi-2 test or Fisher,the exact probability method;Much time point observation data analysis of variance of repeated measurement data,comparison does not meet the integrity,Kruskal Wallis rank and inspection method,repetitive measure analysis of variance with football symmetry,the Greenhouse-Geisser P value,the method of calibration set inspection level is 0.05,P<0.05,the difference was statistically significant.ResultSubjective part 1.Pelvic floor treatment group(30)and control group(30),two groups of patients 6 months after surgery and postoperative PFDI-20,12 months PFIQ-7 scoring significant difference,all P<0.0001,there is statistical significance;Two groups of patients had a significant difference in the score of PFDI-20,and the PFDI scores were significantly reduced in the pelvic floor treatment group.P<0.0001,the difference was statistically significant.Two groups of patients had a significant difference in their sex quality scores in December after surgery,and P<0.0001 was statistically significant.Two groups of patients had a significant difference in contrast quality of life before and after cervical cancer surgery,and P<0.0001,the quality of sex in the pelvic floor treatment group was significantly lower than those in the control group.Objective part 2.The rate of free urinary flow rate was determined by the ratio of free urinary flow in the pelvic floor treatment group and the control group,and the difference was statistically significant.In June,two groups of patients with postoperative 8 weeks postoperatively,in December after maximum urinary flow rate,average urine flow rate P<0.05,the difference was statistically significant,two groups of urination and tmax is P>0.05,there was no statistically significant difference.The physiological functions of the pelvic floor electrophysiology:the physiological functions of the pelvic floor before and after surgery were significantly different,P<0.0001;The two groups of pelvic floor electrophysiological functions were significantly different in December after the operation of the pelvic floor electrophysiological function,and the difference was pronounced in the following month,P<0.0001,in which the difference between the two types of muscle fibers and II muscle fatigue was significant,P<0.05.2.3.A3 feedback:pelvic floor treatment group compared significant difference before and after operation,P<0.0001 difference was statistically significant,the control group(P = 0.141,there was no statistically significant difference,the two groups before and after surgery compared significant difference,P<0.0001 was statistically significant;The two groups were significantly different in June after the operation,and the abnormal rate was statistically significant.Sexual determination:pelvic floor treatment group compared significant difference before and after operation,P<0.0001 difference was statistically significant,the control group(P=0.2223,there was no statistically significant difference,two groups compared significant difference before and after surgery,pelvic floor sexual reflex abnormal rate of treatment group was obviously lower than the control group,P<0.0001 was statistically significant;Both groups were significantly different in December after the operation,and the difference in sexual function in December was significant,both P<0.05 and statistically significant.The successful removal of the urinary canal time was compared to the hospitalization timePelvic floor therapy group(30 people),successful removal of the urinary duct time was 8.63,plus or minus 3.52 days.In the control group(30),the successful removal of the ureter was 10.73 plus or minus 4.40 days,and the two groups successfully removed the urinary control time by P = 0.046<0.05,the difference was statistically significant.The patients were hospitalized in the pelvic floor for 11.80 plus or minus 2.23 days,compared with a control group of 14.63 plus or minus 3.42 days,compared with P<0.001,the difference was statistically significant.ConclusionSubjective part 1.Pelvic floor treatment group(30)and control group(30),two groups of patients 6 months after surgery and postoperative PFDI-20,12 months PFIQ-7 scoring significant difference,all P<0.0001,there is statistical significance;Two groups of patients had a significant difference in the score of PFDI-20,and the PFDI scores were significantly reduced in the pelvic floor treatment group.P<0.0001,the difference was statistically significant.Two groups of patients had a significant difference in their sex quality scores in December after surgery,and P<0.0001 was statistically significant.There was a significant difference in contrast quality in the two groups of patients before and after cervical surgery,and P<0.0001,the quality of sex in the pelvic floor treatment group was significantly better than those in the control group.Objective part 2.2.1.two groups of patients with postoperative urinary retention:pelvic floor number of treatment group appear postoperative urinary retention was 2(6.7%),control the number of patients with postoperative urinary retention of 12 people(40.0%),pelvic floor was significantly lower in treatment group than the control group,P = 0.002,the difference was statistically significant2.2.The successful removal of the urinary canal time and the hospitalization time:Pelvic floor therapy group(30 people),successful removal of the urinary duct time was 8.63,plus or minus 3.52 days.In the control group(30),the successful removal of the ureter was 10.73 plus or minus 4.40 days,and the two groups successfully removed the urinary control time by P = 0.046<0.05,the difference was statistically significant.The patients were hospitalized in the pelvic floor for 11.80 plus or minus 2.23 days,compared with a control group of 14.63 plus or minus 3.42 days,compared with P<0.001,the difference was statistically significant.2.3.The rate of free urinary flow was determined by the ratio of free urinary flow in the pelvic floor treatment group and in the control group,and the difference was statistically significant.In June,two groups of patients with postoperative 8 weeks postoperatively,in December after maximum urinary flow rate,average urine flow rate P<0.05,the difference was statistically significant,two groups of urination and tmax is P>0.05,there was no statistically significant difference.2.4.The physiological functions of the pelvic floor electrophysiology:the physiological functions of the pelvic floor before and after surgery were significantly different,P<0.0001;The two groups of pelvic floor electrophysiological functions were significantly different in December after the operation of the pelvic floor electrophysiological function,and the difference was pronounced in the following month,P<0.0001,in which the difference between the two types of muscle fibers and II muscle fatigue was significant,P<0.05.2.5.A3 feedback:pelvic floor treatment group compared significant difference before and after operation,P<0.0001 difference was statistically significant,the control group(P = 0.141,there was no statistically significant difference,the two groups before and after surgery compared significant difference,P<0.0001 was statistically significant;The two groups were significantly different in June after the operation,and the abnormal rate was statistically significant.Sexual determination:pelvic floor treatment group compared significant difference before and after operation,P<0.0001 difference was statistically significant,the control group(P=0.2223,there was no statistically significant difference,two groups compared significant difference before and after surgery,pelvic floor sexual reflex abnormal rate of treatment group was obviously lower than the control group,P<0.0001 was statistically significant;Both groups were significantly different in December after the operation,and the difference in sexual function in December was significant,both P<0.05 and statistically significant.Conclusion1.Cervical cancer early postoperative for pelvic floor electrical stimulation at low frequency and biofeedback therapeutic intervention,can effectively reduce the chances of appearing urinary retention time placing a urinary catheter can reduce the patients,shorten the patient to hospital stay.2.Low frequency electric stimulation combined biological feedback therapy,can effectively improve the function of patients with postoperative pelvic floor free urine flow rate,electrophysiological function,urinary continence function and sexual reflex.3.The low frequency electrical stimulation with biofeedback therapy,can effectively reduce the impact of postoperative pelvic floor dysfunction on life,improve the quality of cervical cancer patients with postoperative life quality and sexual life.
Keywords/Search Tags:low-frequency electrical stimulation, biofeedback, cervical cancer, pelvic floor dysfunction
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