Nghiên cứu ứng dụng và kết quả phẫu thuật đặt dải băng qua lỗ bịt (trans obturator tape TOT) điều trị tiểu không kiểm soát khi gắng sức ở phụ nữ tt tiếng anh

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Nghiên cứu ứng dụng và kết quả phẫu thuật đặt dải băng qua lỗ bịt (trans obturator tape   TOT) điều trị tiểu không kiểm soát khi gắng sức ở phụ nữ tt tiếng anh

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1 MINISTRY OF EDUCATION AND TRAINING MINISTRY OF NATIONAL DEFENSE VIETNAM MILITARY MEDICAL UNIVERSITY MAI TRONG HUNG RESEARCH ON THE APPLICATION AND OPERATIVE OUTCOMES OF THE TRANSOBURATOR TAPE (TOT) FOR FEMALE STRESS URINARY INCONTINENCE (SUI) Majority: Surgery Code: 9720104 ABSTRACT OF THESIS OF DOCTOR OF MEDICINE HANOI, 2020 The study was complete at VIETNAM MILITARY MEDICAL UNIVERSITY Instructors: M.D., Ph.D., Assoc Prof Vu Huy Nung M.D., Ph.D., Assoc Prof Le Anh Tuan Debator Debator Debator : M.D., Ph.D., Assoc Prof Trieu Trieu Duong : M.D., Ph.D., Assoc Prof Nguyen Ngoc Minh : M.D., Ph.D., Assoc Prof Nguyen Phu Viet The thesis will be dabated and protected in front of the University-level Dissertation Council of Vietnam Military Medical University At……………………………………….… year For further information: National Library Library of Vietnam Military Medical University Library of Central Medicine Information LIST OF RELEVANT STUDIES OF THE AUTHORS UNDER THE PUBLICATION Mai Trong Hung, Vu Huy Nung, Le Anh Tuan (2020) “Assessment on the female SUI treatment outcome by the Transoburator Tape (TOT) surgery”, Vietnam Journal of Medicine and Pharmacy, Edition 1, p.1; Mai Trong Hung, Vu Huy Nung, Le Anh Tuan (2020) “Some indication factors related to the Transoburator Tape (TOT) surgery in the female SUI treatment”, Military Journal of Medicine and Pharmacy, Edition 2, p.127; Mai Trong Hung, Vu Huy Nung, Le Anh Tuan (2020) “Factors related to indications of trans - Obturator tape surgery for the treatment of female stress incontinence” Journal of military pharmaco - Medicine N02-2020 INTRODUCTION Urinary incontinence (UI) is “the involuntary leakage of urine” Urinary incontinence is more common with an estimated 2535% to suffer from it, among them, Stress Urinary Incontinence (SUI) accounted for 53% In 1996, Ulmsten introduced a technique named the Tensionfree Vaginal Tape (TVT) and in 2003, De Lorme developed Transobturator tape (TOT) which the tape is introduced through the obturator foramen, made a big change in the strategy of treating Stress Urinary Incontinence Up to now, it has become the firstpriority technique in the treatment effort of SUI because the method is easy to implement, less intrusive, safe and highly effective In Vietnam, the surgery of Stress Urinary Incontinence by the method of Transobturator Tape (TOT) has only been applied in recent years It is required to carry out further studies to evaluate the longterm outcome of the surgery, and to reduce the rate of complications of surgery being a practical requirement as well Resulted in the afore-said matter, I carried out this research thesis: “Research in application and surgical outcome of Transobturator Tape (TOT) in the treatment of female Stress Urinary Incontinence (SUI)” with targets: Comment on some relevant clinical and subclinical features to the technique of sub urethral transobturator tape in female SUI at Hanoi Obstetrics and Gynecology Hospital Assessment of surgical outcomes of the Transobturator vaginal tape (TOT) in female patients Necessity of the thesis Rates of UI accounted for 25 - 45% of the population, in which SUI is made up for 53% The demand for surgical treatment of female SUI has been increasing rapidly in Vietnam The method of TOT is considered to be the first priority treatment for such patients The safety and effectiveness of the method in the application to Vietnamese patients become an urgent and practical matter that required to be studied further New contribution of the thesis - Carry the technical procedure with 12 simple and easy-toimplement steps - Implement the long-term research and follow-up, further assessment on post-surgical results up to 24 months - Indicate some relevant factors to surgical results such as over-50 age, BMI> 23; pelvic organ prolapse grade II, urinary incontinence grade II and group of patients with Stress Urinary Incontinence grade III Thesis’ layout The thesis consists of 115 pages, including the following parts: introduction (2 pages), overview (33 pages), objectives and research method (24 pages), result (23 pages), discussion (28 pages), conclusion (2 pages), petition: page The thesis includes 34 tables, 22 figures, diagrams and 124 references (English and Vietnamese) CHAPTER OVERVIEW 1.1 Definition and classification of Urinary Incontinence (UI) 1.1.1 Definition of UI According to the International Continence Society-ICS, “Urinary incontinence (UI) is defined as any involuntary leakage of urine and their symptoms, as a social and hygienic matter that related to complaint of quality of life” 1.1.2 Classification of Urinary incontinence In the clinical perspective, urinary incontinence is classified into main types: - Stress Urinary Incontinence (SUI): It happens when the patient exerts pressure on his/ her abdomen by some movements as lifting something heavy, coughing, climbing in a stair, workouts, dance, etc SUI results from the failure of the support system of the pelvic floor or urethral sphincter deficiency - Urge urinary incontinence (UUI): You have such a sudden, intense urge to urinate that you cannot stop the demand even in some minutes, that resulted in an involuntary loss of urine (involuntary loss of urine) - Mixed incontinence: You experience a combination of SUI and UUI 1.2 Surgical treatment of Stress Urinary Incontinence (SUI) * Pubovaginal sling (PVS): The pubovaginal sling (PVS) is a technique using strips of rectus fascia are looped below the bladder neck It is indicated in case that the previous surgical methods failed, or SUI with urethropexy and kinodynamic tests shows low urethral closure pressure or low urinary incontinence (UI) when experiencing the Valsalva maneuver * Burch procedure: The technique of hanging the bladder on Cooper's ligament This was considered the “gold standard” in the treatment of SUI until the late 1990s Research Michael E.A compared the effectiveness of the Burch procedure and the Fascial Sling procedure, the findings showed that after 24 months, female patients who experienced the Fascial sling procedure had higher successful rate than those who experienced the Burch procedure ; however, the Burch group was less Urinary tract infections (UTI), dysuria, SUI than the Fascial Sling group * Mid-urethral slings Mid-urethral slings are considered the gold standard surgical procedure This procedure is more effective than the Burch, featured by shorter operation time and fewer postoperative complications In 2001, Delorme initially reported his research, using a passage to support the urethra via the obturator fossa (the method of TOT) This method also uses artificial needle passage such as The tension-free vaginal tape (TVT) to support the urethra, but it is not placed in the back of the pubis, but through the obturator fossa, aiming to avoid complications such as bladder perforation, intestinal perforation 1.3 Researches to assess the treatment outcomes of SUI by the TOT surgery domestically and internationally 1.3.1 Researches to assess the treatment outcomes of SUI by the TOT surgery internationally In Around the world, many studies mainly compared the outcomes of SUI treatment using the passage TVT and the TOT surgery A number of studies with long-term follow-up period (73 patients within 12 years) indicated that the TOT surgery was a highly-effective technique for the SUI treatment (82,2%) Moreover, there were a number of studies reporting a medium-rate of recovery after treatment with the TOT surgery (64,1%) 1.3.2 Assessments on the outcomes of the TOT in Vietnam Le Si Trung (2006) followed the treatment of 15 patients at Viet Phap Hospital in Hanoi: the mean operation time was 20 mins (15-35 mins) The mean hospitalization time was 23,6 hours (12-36 hrs) There were no complications during the operation time There were no abnormal complications after the surgery except for one patient of delayed wound healing The rate of full recovery reached 93,3% (14/15); improvement by 6,7% (1/15) Le Phuc Lien et al (2011) reported the findings of treatment of 22 patients: The mean operation time was 47,3 minutes, the onemonth follow-up was by 81,8% Nguyen Ngoc Tien (2012) reported the findings of the SUI treatment by the TOT surgery on 126 patients at FV Hospital It showed that a year after hospital discharge and follow-up, the success rate was really high (96.8%), rate of postoperative complications was made up for 19.8% Nguyen Van An et al (2012) reported the findings : the TOT surgery results on 46 patients at Binh Dan Hospital monitored during an mean of 23.6 months ; the success rate accounted for 97%, operative complications consist of a case of bladder perforation and cases of vaginal perforation ; postoperative complications include a case of groin pain, cases of newly-relapsed urgency and a case of prolene mesh extrusion CHAPTER RESEARCH OBJECTIVES AND METHODS 2.1 Research objectives The research targeted the diagnosed female SUI cases, had a positive Bonney test, undergone the transobturator tape (TOT) surgery at the Hanoi Obstetrics and Gynecology Hospital Criteria for patient selection - Female patients are diagnosed with simple or mix stress urinary incontinence SUI, among them, the mix SUI was prominent - Carried out the TOT surgery at Hanoi Obstetrics and Gynecology Hospital for the first time - Had an adequate medical records with data to conduct some research analysis - The patients agree to participate in the research Criteria of patient exception - Female SUI mixed with severe pelvic organ prolapse (Grade III) - Female SUI within 12 month after their deliveries, from the date of surgery Research period The research was conducted during the period of January 1, 2013 and May 2018 2.2 Research methods 2.1.1 Study design Apply the Cohort studies performed cross-section observations at intervals through time 2.1.2 Scope of study sample 10 Apply the formula of sample size calculation for descriptive research to a calculated ratio, n = 48.98 patients There were 59 cases eligible for sampling in the research 2.3 Transobturator Tape (TOT) at Hanoi Obstetrics & Gynecology Hospital It means the “Inside-out” approach (TVT-O), including 12 steps: Step 1: Lying patient position Step 2: Hang two minor slips into thigh creases Step 3: Insert a urinary catheter Step 4: Position the wayout of the bilateral groin’s brackets Step 5: Incise the vaginal wall - Vaginal wall incision of 1.5 cm and underneath the meatus of 1.5 cm Step 6: Separate vagina and tissue around the urethra: Step 7: Dissect by Metzenbaum dissecting scissor: Step 8: Place the TOT needle: Place the guiding tool for the TOT needle with the bracket Take a rotation from a modified handle clockwise (to the right) or counterclockwise (to the left) All maneuvers both rotate and bring the handle in the middle of the vertical axis Place the cord-tipped needle end of the urethra to the the previously defined point on the skin Next, remove the cord and take the TOT needle out toward the opposite direction Repeat the same maneuvers to dissect the vagina and place the needle on the opposite side Step 9: Insert the bracket into the urethra: 18 Normal Birth ≥ 3/6 45/53 0,000 Infant's weight > 4kg 1/6 4/53 0,000 With TSM 1/6 6/53 0,31 Simple 24 Mix 29 Pelvic organ Grade I 42 prolapses Grade II Grade I Grade II 45 Grade I Grade II 14 Grade III 37 Types 0,186 0,000 complex Level of UI Level of SUI 0,000 0,000 Relevant indicative factors to the postoperative relapse of SUI, BMI> 23; number of vaginal deliveries ≥ 3, infant’s weight > 4kg, combined with the prolapse Grade II and Stress Urinary Incontinence Grade III, 4/6 cases of relapses with BMI> 23 CHAPTER DISCUSSION 4.1 Clinical and subclinical characteristics of indications of transobturator tape (TOT) surgery 4.1.1 Age and index of BMI The studied patient age on average was 54,7±10,42 years, of which the youngest was 30 and the eldest was 83 Our findings were higher than those of Ho Nguyen Tien in the SUI treatment by 19 Bandelette underneath the urethra was 51,8±11,9 (the youngest was 39 and the eldest was 67) and the research of Nguyen Tan Cuong in the female UI treatment by TVT surgery was 49,8±7,2 (the youngest was 33 and the eldest was 69) Nguyen Van An et al Introduced a study evaluating the medium-term outcome of the female UI treatment by the TOT surgery on 46 female patients with an average age of 52,0±1,4 years, the youngest was 38 and the eldest was 76 According to Table 3,10, the study group had both slim (10,2%), normal (61,0%) and fat (28,8%) Compared with the results of Nguyen Thi Tan Sinh, there was a relationship between BMI ≥ 22 and the UI status The risk of UI in patients with BMI ≥ 22 was higher than those with BMI 0,05 between UI and BMI level (Table 3,10) Nevertheless, when reviewing each group of the simple SUI and the mix SUI, most patients had a BMI of 18,5 or higher Our results were also consistent with Ho Nguyen Tien with a BMI ≥ 23, accounted for 32% Explanatorily, there were some reasons as overweight that cause frequent abdominal pressure, more pressure on the bladder and urinary incontinence (UI) 4.1.2 Gynecological factors The number of pregnancies and abortions, the number of delivery, the infant’s weight at birth, the vaginal delivery or caesarean delivery as well all have an influence on the female UI Our findings are also consistent with Nguyen Tan Cuong (mean delivery rate accounted for 2,5 times and the highest to 10 times of pregnancy) and Ho Nguyen Tien (mean number of children was 3,4 20 ±1,6, a child at and at max) According to Krue et al 1997, rate of SUI increased from 6,9% before pregnancy to 30,6% after the delivery Giving birth to a heavy baby was also considered as a factor to increase the risk of UI, particularly the infant’s weight of over 4,000g The study of Ebbesen et al evaluated the risk of UI for each delivery as follows: OR = 1.37 (95% CI: 1.04 - 1.79) for a delivery, OR = 1.28 (95% CI: 1.03 – 1.61) for two deliveries and OR = 1.56 (95% CI: 1.26 – 1.95) for three deliveries or more Research findings indicated that patients with the vaginal deliveries of times at maximum (a patient) and also a patient who had not yet delivered but pregnant However, according to S Shirish Sheth, this technique can be carried out in patients who have not given birth yet According to S Shirish Sheth, the TOT surgery has been made on 220 patients who had not yet given birth with the same indications The number of deliveries may be a risk of SUI and did not affect the indications of TOT surgery The matter of number of deliveries has influence on the treatment outcome will be discussed in the following chapter Pelvic Organ Prolapse is the most mentioned disease topic in the study of indications and the SUI treatment outcomes by the TOT surgery as well According to the research’s finding, among patients who was indicated to the TOT surgery, 96,0% of patients had pelvic organ prolapse, 89,8% had cystocele Most of these diseases were treated before surgery but were ineffective and we found a clear influence of the disease on the decision to apply the TOT surgery 21 No patients with pelvic organ prolapse Grade III were indicated to the TOT surgery in the research Pelvic organ prolapse Grade III was not a contraindication of the TOT surgery, but only placing a TOT would not bring benefits to the patients, even it would not be effective and the TOT surgery could cause injuries due to pelvic organ prolapse 4.1.3 Postvoid residual volume According to our findings, most of pre-op cases, 91,5% of patients with postvoid residual volume from 100 – 150 ml and 8,5% of patients with postvoid residual volume > 150 ml In no case did urine residue 23; number of vaginal deliveries ≥ 3; UI Grade II and SUI Grade III; pelvic organ prolapse Grade II Due to the low number of failures, the relevant factors may change It is required to carry out further studies for a larger number of samples Failure rates were not found to be the relevant SUI or the postvoid residual volume in this study The matter of failure of the TOT surgery or relapse of UI is a great concern to further study A study by Ilhan et al in 2017 showed that the angular factor by two ends of the urethral bracket may be a prognostic factor in assessing the outcomes of TOT surgery CONCLUSION 27 Thanks to the treatment outcomes for 59 patients of SUI by the TOT during the period of 2013 - 2018 at Hanoi Obstetrics & Gynecology Hospital, we drawn the following conclusions: Clinical and subclinical characteristics of indications of transobturator tape (TOT) surgery for female SUI The patient age on average indicated for surgery was 54,7 ± 10,42, age of ≥ 50 accounted for 72,9% In which 69,7% of patients had BMI 150ml accounted for 8,5% Đa số bệnh nhân TKKSKGS định phẫu thuật nặng, với 72,9% bệnh nhân xuất TKKS gắng sức nhẹ (mức độ III); có 3,4% bệnh nhân xuất TKKS mức độ gắng sức I; 23,7% mức độ gắng sức II Mức độ TKKS độ chiếm 13,6%, độ 86,4% The majority of patients with SUI when receiving surgery are severe, with 72,9% of patients present with UI at very mild exertion (level III); 3,4% of patients with UI occurred at level of 28 exercise I; 23.7% at exertion level II and The level of TKKS of 1st degree accounts for 13,6%, the 2nd level is 86,4 % Assessment on the female SUI treatment by the TOT surgery 100% of patients successfully performed the TOT surgery “Inside-out” maneuver, with 11 steps of surgical procedure Surgery was performed safely in spinal anesthesia in 94,9% of patients; local anesthesia (1,7%) and intubation (3,4%) The mean operative time was 66,4 ± 21,9 minutes; 98,3% of patients had postoperative time less than hours The mean hospitalization time was 4,6 ± 1,8 days The operative complications by 3,4% with two cases of bleeding; without complications after the surgery The percentage of patients who were catheterized a day after the surgery was 98,3% The TOT techniques for the female SUI treatment were safe, easy-to-implement and recognized a high success rate The success rate at the time of discharge is 100%, up to tons 12 months after surgery Relapse of SUI appeared from 12 months (by 1,7%), up to 8,5% (18 months) and 10,2% (24 months) The success rate after 24 months of hospital discharge was 89,8% The improvement in the postvoid residual volume was significant compared to the Pre-op figure, dropped from 131,7 ± 19,6ml to 49,3 ± 11,7ml at months after the surgery (p 23; pelvic organ prolapse Grade II, UI Grade II, and SUI Grade III 29 VOCABULARY tiểu khơng kiểm sốt gắng sức phụ nữ bệnh viện phụ sản Hà Nội Tiểu khơng kiểm sốt (TKKS) Tiểu khơng kiểm sốt gắng sức (TKKSKGS) Dải băng niệu đạo kỹ thuật đặt dải băng âm đạo đặt dải băng qua lỗ bịt Dải treo mu – âm đạo sa sinh dục Tiểu gấp khơng kiểm sốt đái gấp Tiểu gấp suy thắt niệu đạo đáy chậu Lượng nước tiểu tồn dư sau tiểu số lần tiểu trung bình ngày Trước mổ Bệnh nhân tái phát TKKSKGS Nhóm khơng tái phát Yếu tố sản phụ khoa niệu đạo cố định niệu đạo female Stress Urinary Incontinence/ female SUI Hanoi Obstetrics & Gynecology Hospital Urinary Incontinence (UI) Stress Urinary Incontinence (SUI) mid-urethral sling Tension-free Vaginal Tape: T.V.T transobturator tape/ suburethral transobturator tape/ transobturator vaginal tape (TOT) pubovaginal sling (PVS) Rectus fascia sling pelvic organ prolapse Urge urinary incontinence (UUI) an involuntary loss of urine Urgency urethral sphincter deficiency Pelvic floor postvoid residual volume mean frequency of urination per day Pre-Op/ Pre-surgery SUI Relapse Non-relapse Gynecological factors Urethra urethropexy áp lực khép niệu đạo thấp nghiệm pháp Valsalva Kỹ thuật Burch chậm liền vết mổ biến chứng sau mổ/ hậu phẫu dây chằng Cooper kỹ thuật Fascial Sling nhiễm trùng đường tiết niệu khó tiểu lỗ bịt mảnh ghép nhân tạo T.V.T xương mu thủng ruột thủng bàng quang thủng góc âm đạo đau bẹn đùi lộ mảnh ghép biến chứng mổ test Boney dương tính nghiên cứu tập tiến cứu nghiệm pháp ho bóc tách lỗ niệu đạo kỹ thuật TOT inside-out mổ đẻ số NIT dương tính nếp đùi low urethral closure pressure Valsalva maneuver Burch procedure Delayed Wound Healing postoperative complications Cooper's ligament Fascial Sling procedure Urinary tract infections (UTI) dysuria obturator fossa The tension-free vaginal tape (TVT) pubis intestinal perforation bladder perforation Vaginal perforation Groin Pain prolene mesh protrusion/ exposure/ extrusion operative complications positive Bonney test Cohort study Coughing maneuver dissect meatus "Inside-out" approach (TVT-O) caesarean NIT positive/ positive nitrite thigh creases Kẹp Babcock Thời gian đặt thông tiểu sau mổ sinh đường âm đạo Cầm máu sa thành trước âm đạo viêm bàng quang viêm niệu đạo hố bịt chảy máu – tụ máu khoang Retzius dùng gân tự thân bệnh lý kèm theo gây mê nội khí quản Babcock clamp Time of Post-operative Urinary Catheterization Vaginal delivery hemostasis cystocele/ anterior vaginal prolapse cystitis urethritis obturator Hematoma in the Space of Retzius self-tendons and self-muscles comorbidities Intubation ... VOCABULARY tiểu khơng kiểm sốt gắng sức phụ nữ bệnh viện phụ sản Hà Nội Tiểu khơng kiểm sốt (TKKS) Tiểu khơng kiểm sốt gắng sức (TKKSKGS) Dải băng niệu đạo kỹ thuật đặt dải băng âm đạo đặt dải băng qua. .. âm đạo đặt dải băng qua lỗ bịt Dải treo mu – âm đạo sa sinh dục Tiểu gấp khơng kiểm sốt đái gấp Tiểu gấp suy thắt niệu đạo đáy chậu Lượng nước tiểu tồn dư sau tiểu số lần tiểu trung bình ngày Trước... số bệnh nhân TKKSKGS định phẫu thuật nặng, với 72,9% bệnh nhân xuất TKKS gắng sức nhẹ (mức độ III); có 3,4% bệnh nhân xuất TKKS mức độ gắng sức I; 23,7% mức độ gắng sức II Mức độ TKKS độ chiếm

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Mục lục

  • INTRODUCTION

    • 1.1. Definition and classification of Urinary Incontinence (UI)

      • 1.1.1. Definition of UI

      • 1.2. Surgical treatment of Stress Urinary Incontinence (SUI)

      • 1.3. Researches to assess the treatment outcomes of SUI by the TOT surgery domestically and internationally

        • 1.3.1. Researches to assess the treatment outcomes of SUI by the TOT surgery internationally

        • 1.3.2. Assessments on the outcomes of the TOT in Vietnam

        • CHAPTER 2 RESEARCH OBJECTIVES AND METHODS

          • 2.1. Research objectives

            • Research period

            • 2.2. Research methods

              • 2.1.1. Study design

              • 2.1.2. Scope of study sample

              • 2.3. Transobturator Tape (TOT) at Hanoi Obstetrics & Gynecology Hospital

              • 2.4. Research criteria

                • 2.4.1. Clinical and subclinical indicators related to surgery indications

                • 2.5. Data management and analysis

                • CHAPTER 3

                • STUDY RESULTS

                  • 3.1. Clinical and subclinical characteristics related to the indicated Transobturator Tape (TOT) surgery

                  • Table 3.10. BMI and Pre-operative SUI classification (n=59)

                  • Table 3.11. Postvoid residual volume (n=59)

                    • 3.2. Assessment on the technical outcomes of TOT in the treatment of female SUI

                    • 3.3. Assessment on the treatment outcomes of TOT in the treatment of female SUI

                      • 3.3.1. Postoperative results and post-hospitalization results

                      • 3.3.2. Treatment results of 1-month hospital discharge

                      • Table 3.23: Results of Pre-op treatment and 1-month Postoperative treatment

                        • 3.3.3. Outcomes of 4 months after hospital discharge

                        • 3.3.4. Outcomes of 6 months after hospital discharge

                        • 3.3.6. Outcomes of 12 months after hospital discharge

                        • 3.3.7. Outcomes of 18 months after hospital discharge

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