| Objective:To objectively evaluate the effects of traditional Chinese medicine "Tiaoqi Fuhua Decoction" combined with pelvic floor muscle exercise on the recovery of urinary control,quality of life and bad mood of urinary incontinence patients after radical prostatectomy,and to study the therapeutic effect of the drug,so as to offer a new theory foundation and therapeutic thinking for the therapy of the disease.Methods1.Trial design:This study is a multicenter,prospective,observational Cohort study.2.Subjects:60 consecutive patients with stress Urinary incontinence(SUI)after radical prostatectomy(RP)who visited the urological clinic of Guang’anmen Hospital or the outpatient clinic of Peking University First Hospital from July 2022 to March 2023 were included.According to whether they took Chinese medicine or not,they were divided into a Chinese medicine treatment group and a control group,with 30 cases in each group.3.Intervention measures and planbasic treatment:patients in both groups received behavioral therapy guidance after removing the catheter after operation.Family members are required to accompany and master the training points so as to play a role of supervision and guidance in the training process of patients in the future.At the same time,the patients should be given psychological counseling to make them have firm confidence in the cure,and encourage them to drink water normally to ensure that the daily drinking volume is 1500-2000ml.Control group:pelvic floor muscle training;The specific training methods are as follows:relax and stand all over the body(upright or flat position can also be used),contract the muscles at the bottom of the basin and lift the anus upward,breathe as usual during the movement,and keep the rest of the body relaxed.Touch the abdomen with your hand.If the abdomen is tight,it means that the movement is wrong.The way of force is to consciously control the urine flow,contract the perineal muscles and stop defecation.A group of 20 contractions and relaxations with an interval of 5 seconds and 20 contractions and relaxations with an interval of 1 second is divided into two groups at the time of waking up in the morning,half an hour after lunch,and before going to bed in the evening,for 30 consecutive days.Treatment group:add Tiaoqi Fuhua Decoction to the control group.Its recipe consists of 30g of roasted Astragalus membranaceus,6g of asclepi,6g of Radix Bupleurum,10g of Pericarpium Citri Reticulatae,10g of Radix Zedoariae,10g of Atractylodes Macrocephala,10g of Poria,9g of Almond,6g of Radix Platycodon,and 9g of Epimedium.Based on the patient’s four examinations,the basic formula of Tiaoqi Fuhua Decoction is to add or subtract drugs according to the evidence,theoretically adding or subtracting no more than four flavors.Granules,oral,twice daily for 2 weeks for treatment.Re-diagnosis should be carried out once between the two treatment cycles.Based on Tiaoqi Fuhua Decoction,drug may be added or subtracted in accordance with symptoms.As a rule,the added or subtracted taste of a drug will not exceed 4.Outcome indicatorsMain efficacy indicators:The ICI-Q-SF scale;Secondary other efficacy indicators:72h urine pad dosage,TCM evidence score,I-QOL scale,SAS scale and SDS scale.Safety indicators include UKU Scale and adverse event record form.The primary efficacy index and the secondary efficacy index were recorded once before and 4 weeks after the drug administration.Research results(1)The ICI-Q-SF scale,72h urine pad dosage,TCM evidence score,I-QOL scale,SAS scale and SDS scale were compared before and after treatment in the two groups respectively,and the results indicated that all the indexes were significantly lower than those before treatment(P<0.001),indicating that patients in both groups showed significant improvement in symptoms after 1 course of treatment compared to before treatment.(2)The differences in the evaluation of ICI-Q-SF scale,72h urine pad use,TCM evidence score,I-QOL scale,SAS scale and SDS scale were compared between the two groups before and after treatment,and all the above indicators improved better in the treatment group than in the control group,and there was a significant difference(P<0.05),indicating that the patients in the treatment group improved their symptoms more than the control group after receiving 1 course of treatment significant.(3)The difference between the two groups was significant(P<0.05),indicating that the clinical efficacy of the treatment group was better than that of the control group.Comparison of the healing rate:The healing rate of the treatment group was 56%and that of the control group was 25%,which was significantly higher than that of the control group.(4)Spearman’s correlation analysis indicated that the clinical outcomes were significantly correlated with I-QOL,SAS and SDS scores,and all three correlations were significantly positive.Research Conclusion:(1)Both pelvic floor muscle training treatment alone and pelvic floor muscle training treatment combined with Tiaoqi Fuhua Decoction have a beneficial effect on the recovery of urinary control ability after radical prostatectomy surgery.(2)The combination of Tiaoqi Fuhua Decoction with pelvic floor muscle training treatment had better effects than pelvic floor muscle training treatment alone,which not only significantly improved patients’ urinary incontinence symptoms,but also relieved patients’ anxiety and depression and other adverse emotions,and improved their quality of life. |
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