婦女尿失禁手術之新趨勢 尿失禁暨排尿障礙中心婦產部婦女泌尿暨骨盆重建科孫茂榮主任

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1 婦女尿失禁手術之新趨勢 尿失禁暨排尿障礙中心婦產部婦女泌尿暨骨盆重建科孫茂榮主任 1

2 婦女尿失禁之治療 保守性治療 :( 90%) 中度或輕度尿失禁無法接受手術, 尚未完成生育者 凱格爾運動 ( 骨盆底肌肉收縮運動 ) 生理回饋法 電刺激治療, 體外磁波療法 藥物 手術治療 :(10%) 嚴重尿失禁或以保守治療無效 Mechanism of USI Pressure Transmission Theory - Enhorning Defect transmission of abdominal pressure to the proximal urethra due to weakening in the support of urethra 2

3 For Hypermobility: Traditional Slings Urethrocytopexies Colposuspension For ISD Classical slings Sucessfully, but major, invasive surgery BLADDER NECK ILEO-PECTINEAL LIGAMENT Burch Colposuspension 3

4 COMPLICATIONS OF BURCH COLPOSUSPENSION voiding disorders 12.5% (3-32%) genitourinary prolapse 13.6% ( %) pelvic pain up to 12% de novo detrusor instability 9.6% (4-18%) Jarvis, BJOG Feb

5 THE OBJECTIVE CURE RATE FOR PRIMARY INCONTINENCE SURGERY Procedure Mean(%) 95% CI Bladder buttress M-M-K Colposuspension Non-endo BNS BNS Bladder sling Injectables Jarvis BJOG Feb 1994 WHY DID THE SURGERY FAIL? Inappropriate procedure or suture material. Lack of surgical expertise. Inherent deficiency in tissue quality or post-op healing. Persistent increase in intraabdominal pressure.? Lack of reinforcement (mesh). 5

6 PROBLEMS ASSOCIATED WITH CONTINENCE SURGERIES Low success rate or high recurrence rate Complications Worsening of pre-existing conditions Is there any continence surgery with comparable success rate but with fewer morbidity and long term complications? 6

7 Yes!!! Minimally invasive tape surgery (TVT, SPARC, TVT-O,MONARC,TVT- SECUR,MINIARC) The Hammock Hypothesis 1. The urethra lies on a supportive layer - endopelvic fascia and anterior vaginal wall 2. The stability of the suburethral layer depends on the intact connection of the vaginal wall and endopelvic fascia to the arcus tendineus faciae pelvis and levator ani muscle ~ De Lancey

8 Opening and closure of inner urethra and bladder neck 1. The tension of puburethral ligament (PUL) 2. The activity of the pubococcygens muscles (PCM) and levator muscles (LP= levator plate; LMA= longitudinal muscle of the anus) 3. Suburethral vaginal hammock ~ Ulmsten

9 Vaginal Hammock Theory -DeLancey Defective pubo-urethral ligament, suburethral vaginal wall & pubococcygeus muscles cause weak hammock effects against abdominal pressure Mechanism of USI Integral Theory -Ulmsten 9

10 Tension-free Vaginal Tape (TVT) - Ulmsten 1996 The first new generation of minimally invasive operations for treatment of female USI Reinforcing functional" pubourethral ligaments, thereby securing proper fixation of the midurethral to the pubic bone Reinforcing the suburethral vaginal hammock and its connection to the pubococcygeous muscles GYNECARE TVT Device 10

11 TYPE I TAPE TVT procedure 22 11

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13 TVT Mechanism ~ Ulmsten 1996 TVT creates new pubourethral ligaments Main objectives for TVT technique To support the mid-urethra so the closing abilities of the organ are most effective To ensure that the urethra is not lifted but rather just supported tension-free in the correctional position through the creation of a new urethral ligament Int Urogynecol J 1996;7:81-86 Mechanism of GSUI - why GYNECARE TVT works 13

14 TVT SURGERY Cure rate 80%, improvement 14% Complications : De novo DI 3 15% short term voiding difficulties 4.3% bladder perforation 3.8% urethral erosion few cases significant bleeding few cases Cost effective shorter hospital stay TVT Introduced paraurethrally and retropubically using a mm cone tip trocar Those organ and tissue near the passage of the trocar are vulnerable to injury Reported complication, included bladder injury and rare but life-threatening injuries to the bowels or large vessels 14

15 New Advancement in suburethral sling Modern slings Recent Mid-urethra tape Dynamic kinking Tension-free tape Special designed tools Material : artificial Type 1 Prolene, All type of USI Classical slings Ancient Bladder neck Compression Tension tape Conventional tools Material : artificial & organic Mersilene Marlex Type III or recurrent USI TVT clinical data (1) Merlin T 2001, Nilsson CG. 2003, Lo year cure rate : 80-84% 84% (7 year, 81%) Mean OP time : min Median blood loss : 75 ml Mean hospital stay : < 0.3 to 3 days 15

16 TVT in ISD and mixed incontinence n Cured Improved Years ISD Rezapour M & Ulmsten U Int Urogynaecol J, 2001,2, % 12% 5yrs Mixed Incont. Rezapour M & Ulmsten U nt Urogynaecol J, 2001,2, % 6% 5yrs Recurrent SUI Rezapour M & Ulmsten U Int Urogynaecol J, 2001,2, % 9% 5yrs Cure= <10g/24 hr pad test, CST negative, satisfaction >90% TVT clinical data (3) Total complication rate : % Complications of SUI operation Complications TVT 1 Burch 2 Sling 3 Voiding difficulty 4% 4 11~25% 11% De Novo Detrusor Instability 5.9% 5 12~18.5% 14% Bladder injury 9% 2% Vaginal perforation 3% 0% DVT 0% 2% Incisional hernia 0% 2% Retropubic hematoma 2% 0% Vascular injury 0.6% 0% Tape erosion 0.6% N/A 1. UK prospective randomized controlled study 2. Jarvis, meta-analysis 3. Meta-analysis 4. Meschia, Int Urogynecol J (2001) 5. Nilsson, Int Urogynecol J (2001) 16

17 What is SPARC? 34 17

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19 The transobturator approach tape (TOT;Monarc) Deloreme 2001 Placed the tape between the two obturator foramen Creating a real hammock supporting the urethra instend of urethral suspension as with TVT Why the Obturator Approach? 1.Potential benefits of avoiding retropubic space may include Minimizing risk of bladder perforation, especially in patients who have had prior surgery Minimizing risk of retropubic hematoma Avoidance of bowel injury Reduction in major vascular injury 2.Hammock-shape mesh with lateral fixation mimics normal pubourethral support. 3.Potential benefits of the sling orientation (i.e., hammock shape) may include lower incidence of retention and/or de novo urgency 4.Physicians find speed of procedure appealing 19

20 Monarc Mesh Position Monarc SPARC/TVT Reiffenstuhl,Platzer & Knapstein Obturator Anatomy Adductor longus insertion Urethra Obturator canal SAFE ENTRY ZONE FOR NEEDLE INSERTION 20

21 Monarc Subfascial Hammock Innovative subfascial approach that avoids retropubic space and creates restorative hammock, mimicking the patient s natural anatomy. Monarc & Normal PU Ligament LA = Levator Ani U = Urethra V = Vagina 21

22 TOT procedures (Monarc) Meatus Midurethra 1.0cm 1.5cm-2.0cm Bladder neck 請美國醫師 Dr. Davila 引進最新尿失禁 Monarc 手術示範 22

23 Surgical outcome base on stress test and Pad test at 3~6 months postoperation Outcome TOT (N=74) SPARC (N=32) P Value Cured * N 58 % 80.6 N 29 % Cured ** * stress test: negative, pad test :Dry **stress test: negative, pad test < 2gm CCH GYNECARE TVT Obturator System DEVICE -Plastic Tube with conical tip, connected to blue PROLENE mesh with sheath (same mesh) - Plastic tube and assembly materials: - Polyethylene -Polyurethane - Diameter of Plastic Tube is 4.2 mm at tip, increasing to 4.8 mm at base) HELICAL PASSER - Pre-assembled to Plastic Tube - Detent to hold Plastic Tube in place (snap fit) - Materials: - Polycarbonate Handle - Stainless Steel wire 23

24 GYNECARE TVT Obturator System Winged Guide facilitates accurate and consistent introduction and passage of the Helical Passer It is 6 cm in length and designed to be increased to 7 cm by bending the tabs (Wings limit ability to reach the neurovascular bundle, which is approx 10 cm from midline) Bendable Tabs 6 cm 7 cm TVTO procedures 24

25 Novel surgical technique for the treatment of female stress urinary incontinence? Transobturator vaginal tape inside-out Sample: 107 patients with USI (17 previous OP) short F/U time (one month) Mean Age: 62 years Mean OP time: 14 min (range:7 20) Hospital stay: 1.8 day (0.5-8) Anesthesia: spinal, 82; general, 24; local, 1) Complications Vaginal erosion: 1 Complete urine retention: 3 (2.8%, associate prolapse OP) Pain at thigh folds : 27 (15.9%), relieve in short period. Bladder, urethral injuries, vascular or neurological : nil. Conclusions: TVT-O for is feasible, accurate, and quick. Cystoscopy is not necessary. Leval JD. Euro Urology 2003 Obturator nerve and TVT-O tape 25

26 An anatomical Study of the Obtruator Canal and Dorsal Nerve of the Clitoris and their Relationship to Transobturator slings Achtari C1, McKenzie B2, Briggs Cw, Rosamilia A1, Dwyer P1 1. Mercy Hospital for Women, 2. Department of anatomy and cell biology ICS/IUGA, Paris, France 2004 abstract 86 Results: Dorsal nerve of clitoris Obturator canal Median (range) Mean±Std Dev Median (range) Mean ± std Dev TVT 16mm (12-22) 16.2±4.4mm TVT 40mm (35-44) 40 ± 3.4mm SPARC 15mm (11-19) 15.2±3.0mm SPARC 41mm (35-43) 40.2±3.1mm Monarc 15mm (10-16) 13.8±2.7mm Monarc 25mm (22-30) 25.2±2.9mm TVT-O 14mm (10-15) 13.2±2.2mm TVT-O 20mm (17-23) 19.6±2.3mm Transobturator tape for USI outside-in (Monarc) inside-out (TVT-O) From Deloreme 2001 de Leval J 2003 Cure rate % 90% Tape to obt 25.2mm 19.6mm Canal Procedure fast (12-15min) minimal dissection easy learn minimal migration away from bladder and urethra midurethra placement Complication thigh bladder, urethral, vaginai vulva hematoma, injury, hematoma, thigh pain (15.9%) retention disability/pain (12.9% -- (2.8%--de Leval J) Alex C. Wang), retention (0.9%--Devila) Cystoscopy recommended by some no need authors Charge 自費 ( 約 NT$20,000) 健保給付 ( 約 NT$16,000) 26

27 COMPLICATIONS OF SLING PROCEDURES vaginal erosion 0 16% urethral erosion 0 5% de novo DI % removal % voiding difficulties 10.8% self catheterisation 2% Bidmead J et al BJOG 2000 Synthetic Midurethral Slings Third Generation GYNECARE TVT SECUR* System Sling 8 cm long Requires only a small vaginal incision No exit points Unique tension-free fixation mechanism 27

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29 GYNECARE TVT SECUR System Inserters The mesh is introduced into the patient using curved sterile stainless steel inserter instruments They are attached to a standard needle driver and act as stabilizers for controlled insertion The inserters' tips are designed to cut a precise tissue opening in order to ensure good tissue stability. 29

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31 GYNECARE TVT SECUR System How does it function? The Absorbable Fixation Tips stiffen the mesh for insertion and initial holding of the sling and add tactile feedback during placement Insertion devices cut a precise tissue opening for controlled insertion and good initial fixation Fixation ends are in sturdy tissue adjacent to the same boney structures as GYNECARE TVT and GYNECARE TVT Obturator Same initial pathway as GYNECARE TVT and GYNECARE TVT Obturator The unique attach & release mechanism secures and releases the implant 31

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33 TVT SESUR SYSTEM TVT SESUR SYSTEM 33

34 TVT SESUR SYSTEM TVT SESUR SYSTEM 34

35 Miniarc Miniarc 35

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37 MiniArc's benefits A single-incision approach that reduces the potential for pain Procedure uses a smaller implant and is faster to perform than traditional sling surgeries Outpatient procedure that can be done under local anesthesia Use of proven AMS mesh that facilitates healing New trends in anti-sui surgeries Traditional anti-sui surgeries Midurethral tension free tape 1996 (TVT, SPARC, retropubic approuch) Transobturator approach (outside-in ) URATAPE, Monarc -Deloreme 2001 Transobturator approach (inside-out) TVT-O -de Leval J SINGLE-INCISION SLING SYSTEM(Miniarc,TVT SECUR) 37

38 Mid-urethra sling 廠牌 Transvirginal sling Suprapubic sling Transobturator Gynecare TVT TVT-A TVT-O AMS Tyco IVS Sparc Monarc Cook Stratasis TF Stratasis TF Boston Scientific Advantage Lynx Obtrys 台灣有販售之產品 TVT, TVT-O,, Monarc,Sparc,Miniarc,TVT SECUR 有健保給付之產品 TVT, TVT-O, Sparc 本中心邀請國外專家至本院引進最新尿失禁及骨盆重建手術 38

39 本科邀請國外專家引進尿失禁骨盆重建手術中區尿失禁現代手術治療研討會與操作示範 39

40 中部各大醫院醫師至本院觀摩學習婦女泌尿手術 Thank for your attention! 40