This study was formally approved by the ethics committee of The Second Affiliated Hospital of Zhejiang Chinese Medical University (IRB No.2020-KL-167-01). Since this is a retrospective study, the ethics committee has abandoned the written notification requirement for informed consent. But we still obtained informed consent from all subjects (all patients have the ability to act independently), and they have informed and agreed to this study.All methods were carried out in accordance with relevant guidelines and regulations.
Through the medical record system of our hospital, 96 patients who underwent radical prostatectomy were retrospectively included. The operations were performed by the same surgeon (before that, the surgeon completed approximately 50 cases of laparoscopic radical prostatectomy).
According to the different interventions they received, they were assigned to the micturition interruption exercise group and the Kegel exercise group. 48 patients received micturition interruption exercise and were assigned to observation, while another 48 patients received Kegel exercise and were assigned to the control group. Patients in both groups were followed up for at least 6 months. Follow up by telephone or urology clinic at 1, 3, and 6 months.
1.3 Eligibility criteria
This retrospective study was conducted in the Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine from August 2016 to August 2020. All 96 patients were diagnosed with urinary incontinence after radical prostatectomy. Inclusion criteria include: ≥50 years old, pathologically diagnosed as prostate cancer, normal cognitive function, able to complete urination interruption exercise and follow-up; moderate and above urinary incontinence was diagnosed by 1-hour urine pad test; urination function was not significantly affected before surgery, urinary incontinence occurred after RP; no pelvic surgery in the past Surgery; the patient or primary caregiver agrees to the care plan. Exclusion criteria include: previous history of prostate surgery; combined with severe heart, lung, liver, kidney, brain and other dysfunctions (expected to be unable to continue exercising).
After the catheter was removed, evaluating the presence of urinary incontinence according to AUA/SUFU urinary incontinence guidelines. A 1-hour urine pad test was performed by placing a weighed dry urine pad on the perineum in advance, and the patient was instructed to drink 500 ml of boiled water within the first 15 minutes and rest in bed. In the next 30 minutes, the patient walked up and down the steps; in the last 15 minutes, the patient sat and stood 10 times, coughed 10 times, ran for 1 min, picked up five small objects on the ground, and washed hands with tap water for 1 min. After the test, the placed urine pad was weighed, and the patient was asked to urinate and measure the urine output. The urine leakage volume ≥ 2 g was positive, and the urine leakage volume was ≥ 5 g; that is, the degree of urinary incontinence was moderate or above.
48 patients in the observation group performed urination interruption exercises: during normal urination, the patients were instructed to consciously contract the perineal muscles, stop urination, and actively control urination. After the patient feels that he has stopped urinating, he urinates again and actively interrupts urination again. Repeat until urination is complete. After the patient masters the weaning exercise, it is recommended to perform this exercise when not urinating, that is, contract the abdomen, perineum, and anus at the same time, so that the perineal muscles feel sore. Another 48 patients in the control group received Kegel exercises: first lie down, relax the abdomen, chest, thighs and buttocks, feel the position of the pelvic floor muscles, then contract the pelvic floor muscles for 3 seconds, then relax for 3 seconds, and repeat 10 times. In 3 groups a day, the patients can feel the muscle contraction by putting their fingers into the rectum. The course of treatment was determined on the patient's urinary control and recovery.
1.5 Observation indicators
The follow-up content included the patient's Kegel exercise and micturition interruption exercise status and urination interval. The time, the number of urinations per day, and urinary incontinence status were investigated using the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF), and the difficulties encountered by the patients in the training process were intervened and guided. In the 6th month, the patient was informed to come to the hospital for reexamination to learn more about the implementation of the micturition interruption exercise after discharge, compliance, and urinary control function recovery.
1.6 Sample size calculation
This study was a retrospective controlled study, and the observation index was the recovery time of urinary incontinence. According to estimates, the prevalence rate in the observation group at one month after surgery was 75%, and the prevalence rate in the control group was 95%, α=0.05, and the power was 80%. Using SAS 9.4 software to calculate, the sample size of the observation group N1=47 cases, the sample size of the control group N2=47 cases, a total of at least 94 subjects were included. The results of each test index were consistently significant between the two groups. Therefore, the influence of chance could be excluded, which indicates that there were indeed differences between the two groups.
1.7 Statistical methods
Data were processed using SPSS 25.0. Enumeration data were represented by cases(n%); The measurement data with normal distribution is expressed as `x±s, and the comparison between the two groups is performed by one-way analysis of variance; the measurement data with skewed distribution between the two groups are compared by the rank sum-test. A multivariate binary logistic regression model was used to analyze the influencing factors of rapid postoperative urinary incontinence recovery. correlation analysis was performed by Spearman correlation analysis. Significance was set at an alpha level of .05, with a statistical power of .95.