Identifying indications of tot surgery for the treatment of female stress incontinence

Journal of military pharmaco-medicine n 0 1-2020 218 IDENTIFYING INDICATIONS OF TOT SURGERY FOR THE TREATMENT OF FEMALE STRESS INCONTINENCE Mai Trong Hung1; Vu Huy Nung2; Le Anh Tuan3 SUMMARY Objectives: To identify the indications of TOT surgery for the treatment of female stress incontinence. Subjects and methods: A cross-sectional study on 74 women with stress urinary incontinence who underwent the procedure in Hanoi Obstetrics and Gynecology Hospital from 1 - 1 - 2013 to 5 - 2018. Results and conclusions: Patients with urination (100%) associated with dysuria 80.7%, genital prolapse 96.8%. Patients with associated urination had urination disorders such as exertion during urination, urgency (urination) (58.1%), or both. Patients with urinary incontinence accompanied by urination disorders such as concomitant bowel movements (19.4%), accompanied by inactive bowel movements (29%). When examining the condition of the muscles of the bladder, urethra: Positive Valsalva tests; positive cough test (100%). The amount of residual urine measured by catheterization > 100 mL, and the feeling of wanting to urinate but difficult to urinate (100%). Maternity status, number of pregnancies, number of births, the heaviest birth weight and method of delivery are factors that influence the indications for TOT surgery. * Keywords: Female stress incontinence; Indication of surgery; TOT surgery. INTRODUCTION As defined by the International Continents Society (ICS) for uncontrolled urination: "Uncontrolled urination or urination is an unexplained urinary outflow will, is a social and sanitary issue related to complaints of quality of life". The disease is mainly found in women, urinary incontinence is a major disease affecting life, psychophysiology, work, and quality of life around the world. The overall rate of incontinence in the community varies from 25 - 45% [7]. Uncontrolled urination is a psychological burden that reduces the quality of life. Since the American Obstetrics & Gynecologist - Howard Kelly (1914) first published the technique of exertion of urinary incontinence [8], many studies on urinary physiology, pathogenesis, epidemiology and preventive treatments have been implemented to reduce the burden of disease on women. However, incontinence has not been reported and adequate treatment has not been addressed in some countries [1]. In Vietnam, due to the current economic conditions and oriental culture, the patient was afraid to go to hospital, so this condition is rarely mentioned at major hospitals and in the community. Understanding the clinical 1. Hanoi Obstetrics and Gynecology Hospital 2. Vietnam Military Medical University 3. 103 Military Hospital Corresponding author: Mai Trong Hung (haiyenhcd@gmail.com) Date received: 15/12/2019 Date accepted: 3/1/2020 Journal of military pharmaco-medicine n 0 1-2020 219 profile of urination in women and the factors involved as well as evaluating current surgical treatment for urination will provide useful information for future treatment and prevention. In Vietnam, female stress incontinence surgery with TOT (trans obturator tape) has only been applied in recent years, inspite of many advantages, there is no comprehensive research on indications, techniques, and effectiveness of this surgery. So we conducted this study: To determine the indications of TOT surgery for the treatment of female stress incontinence. SUBJECTS AND METHODS 1. Subject, location and time. 74 women with stress urinary incontinence underwent the procedure in Hanoi Obstetrics and Gynecology Hospital from 1 - 2013 to 5 - 2018. * Inclusion criteria: - The patients were diagnosed with stress urinary incontinence. - Patients with urinary disorders visited hospital. - Patients agreed to cooperate with conditional research post-surgery monitoring. - Eligibility of surgery. * Exclusion criteria: - All patients did not have surgical indications due to general and local conditions without anesthesia or anesthesia conditions. - Patients did not agree to participate into the study. - Urinary incontinence patient without a surgical indication. 2. Methods. * Research design: A cross-sectional descriptive research method. * Sample size: The entire sampling method. * Research outcomes: - Questioning and clinical examination of patients, exploit medical history and history (according to the sample of the research records), explain to the patients for research cooperation. - Conduct clinical examination to select patients with urination. * Processing and analyzing data: All information about the patients were entered into the variable table of STATA 12.0 statistical software. Use appropriate statistical algorithms descriptive statistics: Statistical analysis (Chi-square test, Fisher exact test, t-test, Wilcoxon rank-sum test). Pearson's correlation coefficient was also calculated when considering the correlation between quantitative variables in the study. Tests were considered to be statistically significant (difference or relevance) when the value p < 0.05. When OR was used, the 95% confidence interval of OR passing 1 was considered not statistically significant. * Ethical issues: The research process always ensures compliance with GCP rules - good clinical trials of the Ministry of Health and ICH. During the research process, the researcher always ensures to adhere to the research protocol. Journal of military pharmaco-medicine n 0 1-2020 220 RESULTS AND DISCUSSION 28 randomized controlled clinical trials (RCT) were involved in the meta-analysis with 2,477 patients in the TOT group. This systematic review and meta-analysis suggested that TOT was better at shortening operative time, the length of hospital stay, the incidence of complications, the blood loss, and leading to score reductions in VAS, IIQ-7, and UDI-6 compared with TVT, indicating TOT to be a more effective and safer method in the treatment of SUI [11]. Table 1: Patient characteristics. Characteristics Number (X ± SD) Percentages (%) Mean age 55.3 ± 10.8 30 - 83 Maternal age (30 - 50) 20 27.0% Out of maternal age (> 50) 54 73.0 % Occupation: Farmer Worker Officer Other workers Others 21 7 8 3 35 28.4 9.5 10.8 4.0 47.3 Education: Not Degree level 1 Degree level 2 Degree level 3 Collage - University 6 22 24 8 5 8.1 29.8 32.4 10.8 6.7 The average age was 55.3 ± 10.8 with the lowest being 30 years old and the highest being 83 years old. Of which, 73% of patients were out of the maternal age. The disease occurred in all professions and education levels. In 28 RCT studies in 2,477 patients treated with TOT surgery, the average age ranged from 50 - 60, of which the most common age was from 52 - 55 years old. Our study showed similar results to an average age of 55. This showed the situation of urinary incidence in Vietnam and in the world had similarities [11]. Our results were higher than study by Ho Nguyen Tien in urinary incontinence treatment by surgery of placed Bandelette under the urethra (the mean age was 51.8 ± 11.9, the lowest was 39 and the highest was 67 years old) [1] and Nguyen Tan Cuong’s study in the treatment of urinary incontinence in women with urethral augmentation (mean age: 49.8 ± 7.2; the lowest was 33 and the highest was 69) [2]. Uniformly, the incidence of urine incontinence increased in age [3, 10]. Age of > 40 had a higher risk of urination (RR = 2.16; 95%CI = 1.86 - 2.57) [10]. Because of its prevalence in the elderly, urination was considered the inevitable normal progression of age. However, urine incontinence should not be considered normal in the elderly, although changes in the bladder and organization in the sub-framework contributed to the occurrence of disease [4]. The proportion of patients with farming occupations accounted for the highest proportion (29%), followed by workers (16.1%). Groups of civil servants and hired laborers accounted for less rate (9.7% and 6.5%). Our results were also consistent with the study by Nguyen Thi Tan Sinh on the situation of work and the working time of patients who have undergone [5]. Journal of military pharmaco-medicine n 0 1-2020 221 Table 2: Distribution of patients by maternity status (n = 74). Maternity status Number Percentage (%) Used to be pregnant: Number of births ≤ 2 Number of births 3 - 4 Number of births > 4 74 12 42 20 100 16.2 61.3 27.0 Vaginal discharge: 1 time > 1 time 56 22 34 75.7 29.7 46.0 Averge time 2.7 ± 1.0 (1 - 6) The results showed that the number of pregnancies and the number of abortions as well as the number of births, the weight of the baby at birth also affected the urination condition of the patient. Our results were also consistent with Nguyen Tan Cuong’s study (average number of births 2.5 times and the highest to 10 pregnancies) [2] and Ho Nguyen Tien’s (average number of children was 3,4 ± 1,6, the lowest was 1 and the highest was 6) [1]. The number of vaginal births affected the dilatation of the perineum. In our study, the number of birth ≥ 2 times accounted for 87.1%. According to Nguyen Tan Cuong, 63% of patients with delivery more than 2.5 times in the total number of patients undergoing TOT surgery [2]. - Distribution of patients by incontinence status (n = 74): Nocturia: 74 patients (100%); urine repeatedly/once: 27 patients (36.5%); pee hard to push: 61 patients (82.4%); the urine flows out without a feeling of urination: 21 patients (28.4%); after finishing, still want to go but don't come out: 47 patients (63.5%); must urinate urgently: 44 patients (59.5%); urinary incontinence when exertion: 42 patients (56.8%); suffering from urinary urgency: 32 patients (43.2%); urinating during sex: 10 patients (13,5%). Thus, it could be seen that the condition of urination was very diverse and clinical types. This result was higher than Ho Nguyen Tien’s findings et al: The rate of accompanying genital prolapse accounted for only 28%, the life with urinary disorders accounted for 30%, but 100% of the patients were hospitalized on the basis of incontinence, in which level 1 was 12%, level 2 was 52% and level 3 was 36% [1]. Our study showed that among the patients with urination, 100% of the patients had urination on exertion, 58.1% had urgent and coordinated urination. 22.6% of patients had urinary incontinence during intercourse, 19.4% urinary incontinence associated with feces and 29% urinary incontinence accompanied by inactive feces. Our results were consistent with studies by Nguyen Thi Tan Sinh [5], Nguyen Thi Thanh Tam [3] and Nguyen Thi Ngoc Phuong [4], but higher than Nguyen Tan Cuong’s [2]. - Distribution of patients by reason of admission (n = 74): Urination: 74 patients (100%); genital prolapse: 71 patients (96%), of which genital prolapse level 1: 56 patients (78.9%); level 2: 5 patients (7%); level 3: 10 patients (14.1%); cervical prolapse: 19 patients (25.7%); vaginal prolapse: Journal of military pharmaco-medicine n 0 1-2020 222 66 patients (89.2%); no case of rectal prolapse. Our result was higher than that by Ho Nguyen Tien (the rate of attached sex drive was 28% [1] and by Daher N (the rate associated with genital prolapse was 30%) [9]. - Patient distribution by associated disease and some risk factors (n = 74): Urinary tract infections: 50 patients (67.6%); cystitis: 21 patients (28.4%); trauma to the genital area (cesarean section): 7 patients (9.5%); constipation: 36 patients (48.7%); hemorrhoids: 10 patients (13.5%); menopause: 20 patients (27%); heavy work: 60 patients (81.1%); stress: 60 patients (81.1%). Table 3: Distribution of patients by degree of incontinence upon examination (n = 74). Urinary incidence Number Percentage Urinary incidence during examination: Wet panties (grade 1) Wet outer pants (grade 2) 67 7 90.5 9.5 Time to urinate: Several times/year Several times/month Several times/week 15 54 5 20.2 73 6.8 Table 4: Distribution of study subjects according to BMI and urination status (n = 74). Exertion Urgent Total BMI n % n % n % < 18.5 4 9.5 4 12.5 8 10.8 18,5 - 22.9 26 61.9 21 65.6 47 63.5 ≥ 23 12 28.6 7 21.9 19 25.7 Among patients with incontinence, 10.8% of patients were considered thin, 63.5% had normal BMI, and 25.7% were obese. In terms of exertion and urgency of urinary incontinence at BMI, levels were not statistically significant with p > 0.05. In 28 RCT studies in 2,477 patients treated with TOT method, BMI from 25 - 30 was rated as obese. In our study, the proportion of patients with BMI > 25 was very small, focused mainly on BMI from 21 - 23. This was a big difference in our research compared to other studies in the world [11]. Compared to the study by Nguyen Thi Tan Sinh [5], there was a relationship between BMI ≥ 22 and urination status. The risk of having urinary incontinence in people with BMI ≥ 22 was higher than those with BMI < 22 with OR = 1.77, 95%CI: 1.31 - 2.4). Our results also showed a gradual Journal of military pharmaco-medicine n 0 1-2020 223 increase in urination incidence and BMI. Our results were also consistent with study by Ho Nguyen Tien with 32% of patients having BMI ≥ 23) [1]. - Evaluation of patients through diagnostic tests (n = 74): 73 patients (98.7%) whose Valsalva and cough tests were positive and 2 patients (2.7%) had negative Bonney tests. Our results were also consistent with studies by domestic authors [3, 5, 6]. 100% of patients had the amount of urine remaining after urinating before surgery > 100 mL; of which 65 cases (87.8%) had the amount of urine remaining after urinating from 100 - 150 mL, and 9 cases (12.2%) had urine residues > 150 mL. The average residual urine volume of all patients was 132.6 ± 19.5 mL; of which the lowest was 100 mL and the largest was 170 mL. There was no difference in the average amount of residual urine by urinary incidence (minor incontinence: 132.6 ± 19.4 mL; moderate incontinence: 134.3 ± 19.9 mL). Our findings were also consistent with studies by Nguyen Tan Cuong [2] and Le Si Trung [6]. Figure 1: Relationship between age and residual urine (n = 74). There was no statistically significant difference in the proportion of urine residues by level between the age groups of 30 - 49 and > 50, p > 0.05 (Fisher’s exact = 0.696). Table 5: Some biochemical indicators by degree of urination. Indicators Grade 1 Grade 2 p-values Red blood cells 4.5 ± 0.4 4.5 ± 0.2 0,61a White blood cells 7.9 ± 6.5 6.7 ± 1.4 0,64b 85 15 88.9 11.1 0 50 100 ? 100 - 150 mL > 150 mL Age of 30 - 49 Age > 50 Linear (Age of 30 - 49) Linear (Age > 50) Journal of military pharmaco-medicine n 0 1-2020 224 Platelets 272.3 ± 51.3 268.1 ± 86.9 0.85b Hemoglobin 130.5 ± 7.7 130.6 ± 7.5 0.98a Ure 4.6 ± 1.3 5 ± 1.5 0.4b Creatinine 66.2 ± 13.3 73.7 ± 9.2 0.11b SGOT 25 ± 9.6 23.9 ± 4.8 0.83b SGPT 24.2 ± 14.1 26.1 ± 4.9 0.48b (a: T-student test; b: Mann - Whitney U test) There was no difference in biochemical indices according to the level of urination with p > 0.05. CONCLUSION Patients with urination (100%) or associated with dysuria (80.7%), or genital prolapse (96.8%). Patients with associated urination had urination disorders such as exertion during urination, urgency (urination) (58.1%), or both. Patients with urinary incontinence accompanied by urination disorders such as concomitant bowel movements (19.4%), accompanied by inactive bowel movements (29%). When examining the condition of the muscles of the bladder, urethra: Positive Valsalva tests; positive cough test (100%). The amount of residual urine measured by catheterization > 100 mL, and the feeling of wanting to urinate but difficult to urinate (100%). Maternity status, number of pregnancies, number of births, heaviest birth weight and method of delivery are factors that influence the indications for TOT surgery. REFERENCES 1. Hồ Nguyễn Tiến, Lê Sỹ Phương, Bạch Cẩm An, Phan Viết Lâm. Kết quả điều trị són tiểu khi gắng sức bằng phẫu thuật đặt Bandelette dưới niệu đạo. Tạp chí Y học TP. Hồ Chí Minh. 2010, 5, tr.32-38. 2. Nguyễn Tân Cương, Từ Thành Trí Dũng, Trần Lê Linh Phương, Vũ Hồng Thịnh, Nguyễn Hoàng Đức. Đánh giá kết quả ban đầu điều trị tiểu không kiểm soát ở phụ nữ bằng nâng niệu đạo kiểu TVT. Tạp chí Y học TP. Hồ Chí Minh. 2009, 13, tr.205-209. 3. Nguyễn Thị Thanh Tâm. Nghiên cứu tỷ lệ són tiểu ở phụ nữ mãn kinh tại Bệnh viện Phụ sản Từ Dũ. Tạp chí Y Dược học TP. Hồ Chí Minh. 2008, 3. 4. Nguyễn Thị Ngọc Phượng. Nghiên cứu tình hình rối loạn tiểu tiện ở phụ nữ trước và sau mãn kinh. Tạp chí Y học Thực hành. 1998, 5. 5. Nguyễn Thị Tân Sinh. Nghiên cứu thực trạng són tiểu và một số yếu tố liên quan ở nữ nhân viên Bệnh viện Bạch Mai. Luận văn Bác sỹ Chuyên khoa Cấp II. Trường Đại học Y khoa Hà Nội. 2007. 6. Lê Sĩ Trung. Điều trị són tiểu ở phụ nữ bằng phương pháp TOT: kinh nghiệm ban đầu qua 15 trường hợp. Tạp chí Y học Việt Nam. 2006, 326, tr.1-6. 7. Hannestad Y.S et al. A community- based epidemiological survey of female urinary incontinence: The Norwegian EPINCOMT study. Epidemiology of Incontinence in the country of Nord - Trondelag. J Clin Epideniol. 2000. 53, Journal of military pharmaco-medicine n 0 1-2020 225 pp.1150-1157. 8. Honna Y et al. Urodynamics. Incontinence 2nd edition, Plymouth, UK. Plymouth Distributors. 2002. 9. Daher N, Gagneur O, Gondry J, Mention J.E, Merviel P, Boulanger J.C. TVT prépubien. Étude prospective longitudinale dans le traitement de l’incontinence urinaire d’effort de la femme : à propos de 164 cas. Gynécologie Obstétrique & Fertilité. 2005, 33, pp.570-576. 10. Davis G et al. Urinary incontinence among female soldiers. Military Medicine. 1999, 164 (9), pp.182-187. 11. Huang Z.M, Xiao H, Ji Z.G, Yan W.G, Zhang Y.S. TVT versus TOT in the treatment of female stress urinary incontinence: A systematic review and meta-analysis. Ther Clin Risk Manag. 2018;14:2293–2303. Published 2018 Nov 20. doi:10.2147/TCRM.S169014