| ObjectiveThrough the registry study method under the real-world study,collect the clinical diagnosis and treatment data of treating urinary incontinence（UI）with acupuncture as the main treatment method in a standardized way,analyze the epidemiological and clinical characteristics of patients with urinary incontinence,use statistical methods to find out the risk factors and protective factors of urinary incontinence,and observe the efficacy and safety of the treatment scheme,and evaluate the effect of acupuncture treatment on the prognosis of urinary incontinence and the quality of life of patients.MethodThis study adopts a prospective and observational registry study design based on the real-world study,takes the case report form as the data collection tool,establishes standard registration operation specifications,and collects the basic information of patients with urinary incontinence and different diagnosis and treatment schemes.The clinical acupuncture treatment scheme of this study is mainly composed of Tiao Shen Qi Zhen,Pang Guang Wu Zhen combined with electroacupuncture,and Wen Shen Ba Zhen combined with electroacupuncture.The scheme of male patients is Tiao Shen Qi Zhen+Pang Guang Wu Zhen combined with electroacupuncture",and the scheme of female patients is Tiao Shen Qi Zhen+Wen Shen Ba Zhen combined with electroacupuncture.Clinical treatment takes this scheme as the basic scheme.During treatment,doctors can make appropriate changes according to the patient’s condition and wishes.In addition,other treatment methods can also be used for cooperation,such as Wen Yang Yi Shen moxibustion,Wen Yang Yi Shen acupoint application,traditional Chinese medicine prescriptions,ear acupoint,Yi Jin Jing,etc.among them,the Yi Jin Jing is taught according to the interests and wishes of patients,and each patient carries out health education before treatment.In terms of data management,doctors or graduate students who have received unified training shall collect the data,and a special person shall be responsible for storage and sorting,so as to ensure the integrity and accuracy of the data.The statistical methods of this study mainly use descriptive statistics,hierarchical analysis,correlation analysis,multivariate regression analysis and logistic regression analysis to explore the impact of various factors on urinary incontinence and the therapeutic effect of acupuncture.Results（1）Completion of the StudyIn this study,68 subjects are enrolled,63 cases are finally completed and 5 cases fall off.（2）Distribution of demographic characteristicsAmong the 68 subjects enrolled in this study,there were 6males（8.8%）and 62 females（91.2%）;The age was 55.34±7.61 years old;BMI was 24.44±2.97;The abdominal circumference was 85.34±8.55cm;Retirement status accounted for the largest proportion in occupations,accounting for 42 cases（61.8%）,and other types accounted for less.The educational background is basically below graduate education,and the total number of university education is 46 cases（67.7%）.（3）Distribution of clinical characteristicsAmong the 68 subjects,the course of disease of most subjects was less than 10 years,the average was 7.42 years,the shortest was 3 days,the longest was 27 years;In the 1-hour urine pad test,there were 49 patients（72.1%）with severe urinary incontinence;The majority of urinary incontinence types are stress and mixed type.Two thirds of the subjects had at least one operation;Subjects with smoking and drinking history accounted for less;62female subjects had childbearing experience,the age of first childbirth was 25.32±2.27,56 subjects had vaginal childbirth,of which 2 cases had two vaginal births,11 cases had caesarean section,and 77.4%of the subjects had abortion;24.2%of the subjects had menopause;More than half of the subjects had pelvic distension（33,48.5%）and chronic constipation（44,64.7%）.The residual urine volume measured by B-ultrasound was 12.25±15.11ml.After the onset of urinary incontinence,only 1/3 of the subjects sought treatment,among which the satisfaction with acupuncture treatment was high.（4）Treatment plan selection and grouping resultsThe 63 subjects were divided into the following two groups according to the choice of treatment scheme:22 subjects who only used acupuncture treatment scheme as group A,and the other 41subjects who selected two or more treatment schemes as group B.The gender,age,height,body weight,BMI,abdominal circumference and course of disease of the two groups were statistically tested,and there was no significant difference between the two groups,balance of baseline data was comparable.（5）Results of correlation analysisPearson linear correlation analysis was carried out with the data of age,BMI,abdominal circumference,course of disease and urine leakage as variables.The results showed that the correlation coefficient between BMI and 1h pad test was r=0.25（P<0.05）,and there was a weak positive correlation between them.Spearman rank correlation analysis was carried out with the data of age group,obesity group,abdominal circumference group and urinary leakage index of 1h pad test as variables.The results showed that the correlation coefficients between smoking history,drinking history and pelvic distension and urinary pad index were r=0.25（P<0.05）,r=0.39（P<0.01）and r=0.37（P<0.01）,respectively,indicating that there was a certain positive correlation between them.Among them,the positive correlation between drinking history,pelvic distension and the degree of urinary leakage in 1H urine pad test can reach medium intensity.In addition,the correlation between pelvic distension and chronic constipation also reaches medium intensity,r=0.53（P<0.01）.（6）Results of regression analysisTaking the grade of urine leakage in 1h pad test as the dependent variable,drinking history,childbearing age and pelvic distension as the independent variables,an ordered multivariate logistic regression analysis was carried out.The results showed that the drinking history（no-yes）,the regression coefficient was-4.476,and showed a significant level of 0.01（z=-2.83,P=0.005<0.01）,or=0.0114（CI 0.000441-0.263）;At the level of childbearing age,the regression coefficient was-0.335,z=-2.20,P=0.028<0.05,or=0.7154（CI 0.520-0.952）;Pelvic distension（no-yes）,regression coefficient value was 2.427,z=2.88,P=0.004<0.01,or=11.3285（CI 2.573-81.098）.（7）Effect of acupuncture on the total number of urinary incontinence in 3-day bladder diaryThe two groups of subjects collected the 3-day bladder diary card data at the four time points before treatment,after 6 times of treatment,after 12 times of treatment and follow-up period,and counted the total number of incontinence,The total times of urinary incontinence in the two groups at four time points after the start of the study were 7.00±5.04,5.86±3.18,3.82±3.52,3.18±2.15 and 7.41±4.71,4.39±3.77,1.59±1.45 and 1.32±1.13respectively;There was no significant difference in the total number of times between the 12 times of treatment and the follow-up period in the comprehensive treatment group（P=0.102>0.05）;Comparison between groups:at the time point before treatment,there was no significant difference between the two groups（P=0.746>0.05）,which was comparable;At the time point after 6times of treatment,there was no significant difference between the two groups（P=0.125>0.05）;There was significant difference between the two groups after 12 times of treatment and at the time point of follow-up（P<0.01）.（8）Effect of acupuncture on urine leakage in 1h pad testThe results showed that the urine leakage of 1h pad test of group A and group B was significantly lower than that before treatment,and the difference between the two groups was statistically significant（P<0.01）;However,group B improved more than group A,and there was no significant difference between the two groups before treatment（P>0.05）,but there was significant difference between the two after treatment（P<0.05）.（9）Effect of acupuncture on the total score of ICIQ-UI SFAfter the start of the study,the total scores of ICIQ-UI SF were recorded at three time nodes:before treatment,after treatment and follow-up.The scores of group A were 11.23±2.27,7.82±4.31 and 6.41±2.04 respectively,and those of group B were12.24±3.04,6.24±4.03 and 5.68±3.63 respectively;There were significant differences in the total scores between the two groups after treatment and before treatment,during follow-up and before treatment,during follow-up and after treatment（P<0.05）;There was no significant difference in the total score between the two groups before treatment（P=0.174>0.05）;At the same time,compared with the follow-up period,FA=2.084（P=0.154>0.05）,FB=0.750（P=0.390>0.05）.There was no significant difference in the total score between the two groups.（10）Effect of acupuncture on the total score of I-QOLAfter the start of the study,the total scores of I-QOL were recorded at three time nodes:before treatment,after treatment and follow-up period.Group A was 51.73±4.32,81.46±2.25 and82.46±2.06 respectively,and group B was 53.20±3.17,87.24±1.65and 85.15±1.51 respectively;The total score of group a continued to increase in the follow-up period（P>0.05）,but the total score of group B decreased compared with that after treatment（P<0.05）,but it was still higher than that of group A;Before treatment,the average total scores of the two groups were 51.73 and 53.20,which were significantly lower than the standard score of 100,and the difference was not statistically significant（P=0.785>0.05）;There was significant difference in the total score between the two groups after treatment（P=0.042<0.05）,and the total score of group B was higher;During the follow-up period,the total score of group B was still higher than that of group A,but there was no significant difference between the two groups（P=0.296>0.05）.（11）Effect of acupuncture on the total score of DASS-21In this study,the DASS-21 data of 63 subjects before and after treatment and during follow-up were counted.The total score was graded according to the grading standard of grade 5.There were 8cases of mild depression and stress,17 cases of mild anxiety,and the grades of other subjects were all normal,of which 3 cases showed mild depression,anxiety and stress at the same time.After one month of treatment and communication,only four subjects had no significant improvement in the scale evaluation,and the scale evaluation scores of the other subjects decreased to a certain extent,among which the depression and stress scores improved most significantly;In the screening period,13 of the 17 cases evaluated as mild anxiety decreased to the normal level.（12）Effect of acupuncture on the total score of PSQIAccording to the grading of PSQI score,the subjects’sleep quality was good,OK,average and poor,accounting for 19%（12/63）,24%（15/63）,30%（19/63）and 27%（17/63）respectively,and more than 80%of the subjects had sleep disorders.PSQI was used to evaluate the sleep of the two groups at three time points:before treatment,after treatment and follow-up period.The total scores were 11.09±4.81,8.23±2.71,7.36±2.90,11.44±5.03,6.24±2.76and 5.98±2.40 respectively;The difference of PSQI total score between the two groups at each time point was statistically significant（P<0.05）;There was no significant difference in the total score between the two groups before treatment（P=0.791>0.05）;After treatment and follow-up,there was significant difference in the total score of PSQI between the two groups（P<0.05）,and the total score of PSQI in group B decreased more significantly than that in group A.（13）Results of safety evaluationAmong the 63 subjects who completed treatment,follow-up and included in statistical analysis,11 acupuncture related safety events occurred in acupuncture related safety evaluation,including2 stabbing pain and 9 subcutaneous bleeding;There were 5 adverse events,including 2 colds,1 scald,1 hospitalization due to primary disease（routine reexamination of cancer）and 1 hospitalization due to low back pain;No serious adverse events occurred.The above stabbing pain,subcutaneous bleeding and scald were relieved after corresponding treatment;In the adverse events,except for scald,it was determined that the correlation with the intervention measures was definitely irrelevant.After the subjects recovered,the measures without change in treatment were taken to continue to complete the study.Conclusion（1）From the analysis of demographic characteristics,it is found that the patients’cognition of urinary incontinence is obviously insufficient,and the treatment rate is low,and the treatment rate of men is only half that of women;There is a trend of rapid outbreak of prevalence in women during menopause with hormone level disorder,and overweight abdominal circumference and BMI may have a significant impact on urinary incontinence.（2）From the analysis of clinical characteristics,it is found that urinary incontinence groups do not pay enough attention to urinary incontinence,and even delay treatment,resulting in a long course of disease,the severity of urinary incontinence leakage is too heavy,and there is a common misconception that urinary incontinence is not a disease,but a"natural manifestation"of old age.At the same time,surgical history,reproductive history,pelvic distension and long-term constipation may lead to urinary incontinence to a certain extent.（3）In the correlation analysis,BMI,drinking history and pelvic distension were positively correlated with the severity of urinary incontinence（urine leakage）;In the regression analysis,drinking history,childbearing age and feeling of distension were the risk factors to aggravate the severity of urinary incontinence（urinary leakage）.（4）Acupuncture based treatment can significantly improve the clinical symptoms of urinary incontinence,improve the quality of life and sleep of patients with urinary incontinence,promote the mental health of patients,and the long-term effect is considerable. |
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