1. Complications of TVT Nader Gad MBChB, MChGO, FRCOG, FRANZCOG Consultant & Senior Lecturer in O&G Royal Darwin Hospital-Darwin-Australia

2. Mid-Urethral Slings Replaced Burch Colposuspension as The most frequently performed procedures for Treatment of Female SUI

3. Cure/Dry Rates of Most Common Procedures for SUI PROCEDURECURE / DRY RATES Burch73% at ≥ 48 months Autologus Facial Sling82% at ≥ 48 months Cadaveric Slings80% at 24 – 47 months Synthetic slings at Bladder Neck73% at 24 – 47 months Synthetic slings at mid-Urethra84% at ≥ 48 months Collage injection48% at 12 -23 months 32% at 24 – 47 months

4. Sling Related Complications Comprehensive Review of 13,700 Patients. Edward et al. J minimally Invasive Surgery. 2008; 15:132 ComplicationNo of studiesPatients No% Voiding Dysfunction888116.3 Detrusor overactivity20195015.4 Urinary retention13120014.4 Pain65977.3 Erosion/Extrusion1621976.0 Infections1914875.5 Dyspareunia21754.3 Injury1018163.3 haematoma436912.0 13, 7378.2

5. USA Federal Drug Administration Manufacturer & User Facility Device Experience Database (MAUDE) Self-reported in > 90,000 TVT Procedures Worldwide ComplicationNumber Small Bowel5 Large Bowel5 Death due to Bowel Injury 2 of large bowel injury were unrecognised at time of surgery & led to sepsis & Death 2 Unspecified1 Urethral Erosion6 Urethro-Vaginal Fistula2 Erosion into Bladder5 Vascular Injury Obturator/External iliac/Femoral/Inferior epigastric 22

6. TVT Related Complications Comparison of 3 Different Countries (Finland / Austria / France) Finnish Nationwide Analysis (1,455) Austrian Registry (2,795) French Survey (12,280) % Bladder Perforation 3.82.77.34 % Urinary Retention 2.3NP6.6 % Haematoma (Retro-pubic or Vulvo-vaginal) 1.90.70.3 Vaginal Defect Healing 0.7NP0.2

7. Overall Risks of TVT Large Series (38 Hospitals) Complication% % Voiding Difficulty Rsidual > 100 ml 48 hrs – 4 months 7.5 Blood loss > 200 ml1.9 Complete Urinary Retention 6 hrs – 6 months 2.3% Retropubic Haematoma1.9 UTI4.1%Major Vascular Injury0.1 Bladder Perforation 3.8%Obturator Nerve Injury0.1 Vesico-vaginal fistula 0.1%Complication requiring Laparotomy 0.3% Data in Kuuva et al. Neurolo Urodyn 2000; 19: 394

8. TVT Most Common Complications Intra-operative bladder puncture Post-operative voiding difficulty

9. TVT Most Common Long Term Complications Nilsson et al. Obstet Gynecol. 2004; 104:1259 Recurrent UTI 7.5% De Novo DI 6.3% Asymptomatic POP 7.8%

10. Intra-Operative Bladder Perforation Mainly with TVT “Rare with TVT-O” Does not cause serious consequences Does not affect cure rate

11. Incidence of Bladder Injury in TVT Incidence: 1 – 15 % Average 5% Incidence is related to experience By Single Experienced Surgeon: 0.8% In multicentre studies: 15%

12. Incidence of Bladder Injury in TVT When By Residents: -Bladder perforation rate: 34% -Diagnosis missed during cystoscopy: 37% Success rate: -< 20 procedures: 74% -> 20 Procedures: 83%

13. Bladder & Urethral Injury More common: Patient left side when right handed surgeon: On Side opposite Surgeon’s dominant hand Repeat Procedures Concomitant Vaginal Surgery

14. Management of Bladder Injury Recognition of injury by Cystoscopy Withdrawal Repositioning slightly more Lateral Bladder Drainage 1-3 days

15. Avoidance of Bladder Injury Empty bladder before dissection & insertion on each side Use Bladder Catheter & Obturator “45 Degree” Finger guidance Keep TVT needle in a plane: -from Mid-Labia Majora toward -Ipsi-lateral Shoulder while -maintaining position directly behind Pubic Bone Consider TOT in high risk women (Incidence < 1%)

16. Urethral Injury If/When it happens: Tape Placement is contraindicated for 6 weeks for adequate healing

17. Avoidance of Urethral Injury Place a catheter Infiltrating Ant Vag Wall with LA or N-saline Sharp dissection Stay superficial to peri-urethral fascia

18. Bleeding During: -Vaginal dissection -Perforation of retropubic space -Needle further passage Injury to external iliac / femoral vessels can have serious consequences

19. Bleeding in Retro-pubic Space Can be difficult to manage Digital pressure for few minutes Close vaginal wall Pack vagina for several hours Persistent heavy bleeding may require Trans- Abdominal to access the retro-pubic space

20. Injury to External Iliac/Femoral Vessels Sudden rapid bleeding during needle passage Caused by: -Exaggerated flexion of the thighs -Excessive lateral passage of needle

21. Haematoma “Symptomatic” Retro-pubic/Vaginal Haematoma: 1 – 5% Conservative management: -Rest -Observation -Antibiotics -Blood transfusion Exploration & Evacuation may be necessary

22. Mesh Extrusion & Erosion TVT Vs Autologus Slings is associated with Quicker recovery Shorter operating time Shorter hospital stay Lower rate of urinary retention “BUT” Mesh Extrusion & Erosion is 10 – 15 times more likely to occur

23. Vaginal Extrusion / Urethral Erosion Monofilament Woven Polypropylene slings: 1% Gor-Tex, Dacron, silicone: 4 – 30%

24. Factors Contribute to Vaginal Extrusion / Urethral Erosion Operative Technique: -Too close to urethra -Inadequate vaginal tissue coverage Poor Vascularity Infection: haematoma predisposes to infection

25. Factors Contribute to Vaginal Extrusion / Urethral Erosion Size of implant Properties of material: pore size, stiffness, elasticity Pores Diameter > 80 um, permit passage of macrophages & tissue in growth ( ↓ I nfection & ↑ Integration) Extrusion & Erosion is rare in TVT/SPARC

26. Urethral Erosion Recurrent UTI Complete removal of “Synthetic” sling Urethral defect should be closed over a catheter Peri-urethral fascia should be approximated If Repair is under tension: placement of labial fat graft Inspect for any bladder erosion Catheter should remain for 2 weeks Post-operative incontinence: 44-83%

27. Bladder Erosion Dysuria Bleeding Urgency Complete removal of synthetic sling It may require partial cystectomy

28. Voiding Dysfunction Most common Post-Operative complication following anti-incontinence surgery Incidence: 2.8 – 14%

29. Causes Inadequate Detrusor Contraction Excessive Tension under Urethra UDA may be used for Differentiation

30. Management of High Residual Urine Timed voiding Double voiding Change Position during Voiding Supra-pubic pressure during voiding Consider UDA Drugs: -Alpha blockers: retentive symptoms/problem -Anti-muscarinics: initiative symptoms/problem

31. Management of High Residual/Urinary Retention Intermittent self catheterisation Indwelling Foley catheter: remove every 3-4 days & trial of voiding Loosen the tape: -Dilator -Foley Catheter

32. How to Loosen Tape Problem persist for > 2 days Office procedure room Lithotomy position Lignocaine (2% Gel) into Urethra Wait 5 min Dilator: gently but firmly pulled straight down Foley catheter Balloon

33. Urinary Retention Need of Catheterisation > 1 week: 4-8% following sling surgery Risk increases with: -Age -Parity -Concomitant Vaginal Surgery -Low Flow -Low Voiding Pressure

34. Urinary Retention If Outflow Obstruction, Identify: -Over-suspension “Hyper-suspension” of Urethra -Obstructing Large Cystocele Posteriorly Properly placed sling does not produce obstruction No quantitative measure of proper sling tension is universally used No ideal method of tensioning has been agreed on

35. Urinary Retention Conservative with CIC ? Alpha-Adrenergic Blockers UDA to demonstrate outlet obstruction is not necessary Sling incision &/or Urethrolysis should be offered regardless of presence or absence of adequate detrusor contractility

36. Problem Persists for 2 months Divide the Tape Lignocaine 1% + adrenaline 1:200,000 under mid- urethra and laterally Lateral 2 cm cut (8 or 4 o’clock) relative to EUM Tape is a firm structure lateral to mid-urethra Cut it with Metzenbaum scissors

37. Urethrolysis when Problem Persists 1-3 months Relieve tension with 50% continence rate (1.9% of 1175) Laurikainen et al. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17:111 Another Study: 61% remained continent (0.6% of 9040) Rardin et al. Obstet Gynecol 2002; 100:898

38. Effect of Delaying Urethrolysis Leng et al. J Urology. 2004; 172:1379 21 patients had Urethrolysis after 2-66 months Average follow up of 17 months Association between prolonged time to Urethrolysis and more likelihood of persistent bladder dysfunction after Urethrolysis

39. Rare “BUT” Serious Complications

40. Death Due To TVT (1999-2005) 8 Deaths 2/32 due to Vascular Injury (6%) 6/33 due to Bowel injury (18%) TVT-O: only one reported death due to sepsis

41. Complicatio n PresentationSource Small Bowel Perforation 56 yrs, Previous TAH +BSO, TVT under epidural 3 Hours after TVT: Acute Lower Abd pain Only abnormal findings: tender RIF + increasing WCC 5 Hours from TVT: laparoscopy for persistent severe pain Trans-fixation of loop of ileum Tape cut Stitches to both sides of ileal loop Discharged day 5 At 6 & 12 months patient is dry Meschia et al. Int Urogyn J 2002; 13: 263 Italy

42. ComplicationPresentationSource Small Bowel Perforation 73 yrs, Previous TAH + BSO. TVT during POP repair Discharged home day 2, Day 3 re-admitted: -nausea, vomiting -Abd distension, bowel contents from TVT exit site -Free air under diaphragm on X-Ray Laparotomy, tape perforated small bowel through & through Tape cut & entirely removed 3 cms of small bowel was resected & 1ry anastomosis was performed PFE helped her incontinence Huffaker et al. Int Urogynecol J. 2010; 21: 251 USA

43. ComplicationPresentationSource Small Bowel Obstruction 73 yrs Vag Hyst + TVT GA Day 3: Low grade temp + mild abdominal distension Day 5: persistence of LGT + Elevated WCC + CT scan: severe intestinal distension Laparotomy: -Massive bowel distension -Perforation of Mesentery by TVT -No bowel perforation Tape was cut & ileum freed Normal recovery Follow up no incontinence Leboeuf L et al. Urology. 2004;63: 1182 USA

44. ComplicationPresentationSource “Delayed” Small Bowel Obstruction 51 yrs, had uneventful TVT 3 Years later presented with small bowel obstruction Laparotomy : -Tape violating peritoneum and -Causing distal ileum to adhere to pelvic side wall Compromised bowel was resected & primary anastomosis performed Phillips et al. Int Urogynecol J. 2009; 20: 367 Canada

45. ComplicationPresentationSource Trans- Urethral Penetration 45 yrs, Uneventful TVT, Normal Cystoscopy On removal of Catheter 3 rd day: urinary retention Supra-pubic catheter : urinary retention continued Suburethral Tape division after 3 weeks: retention continued 2 nd attempt of Tape division One week later: for 2weeks managed to pass urine but high residual of 200mls Complete retention returned : suprapubic catheter 2 months Urethral dilation: passed urine with about 70 ml residual Koeble et al. BJOG. 2001; 108:763 Germany

46. ComplicationPresentationSource Trans- Urethral Penetration One year later: severe urgency, dysuria, nocturia, pelvic pain Cystoscopy: tape passing through upper 3 rd of urethra (from 5 – 7 o’clock) Failure to remove by cystoscopy Colpotomy: impossible to remove due to excessive fibrosis Tape divide & embedded ends of tape were removed from urethral wall Urethra closed with 4/0 polyglactin single knot sutures Catheter for 10 days, No post-operative complications Complete emptying of Bladder, continent Koeble et al. BJOG. 2001; 108:763 Germany

47. ComplicationPresentationSource Uretreral injury 2 ureteral injury in French Survey of immediate Complications of TVT Limited details were available in only one injury: One week following TVT: Ureteral fistula with pelvic cellulites Required surgical treatment May be due to Too Medial & Deep passage of needle Agostini et al. Eur j Obstet Gynecol Reprod Biol. 2006;124: 237 France Necrotizing Fasciitis Uneventful TVT in 62 yrs old 11 days post surgery presented to ED severe lower abd pain, elbow pain, Fever, drainage from suprapubic exit sites Diagnosis of Necrotizing Fasciitis Johnson et al. Int Urogyn J. 2003; 14:291 USA

48. ComplicationPresentationSource Severe Haemorrhage Uneventful TVT in 59 yrs with minimal blood loss Postoperatively: -Growing suprapubic mass -Hb declining: down to 8.4 then 5.2 Conservative approach with blood transfusion Growing and more painful Suprapubic mass Laparotomy 19 hours after TVT: -Large clots in space of Retzius (1,500 gm) -Tape was easily removed -Only source of active bleeding was some oozing in area where Tape enters space of Retzius from under the urethra -These places were sutured & Drain inserted -10 units of blood in total Discharged on 9 th day after laparotomy with still palpable & mildly painful suprapubic swelling 4 months after surgery SUI was similar to before surgery Vierhout ME. Int Urogyn J 2001; 12: 139 Netherlands

49. ComplicationPresentationSource External Iliac Artery Laceration 41yrs old undergoing TVT under LA & Sedation When attempt was made to insert Trochar on Rt side, patient experienced considerable discomfort Analgesia adjusted 2 nd attempt: still in discomfort During 3 rd attempt to pass trochar: -patient flexed her abdominal ms -Lifted her buttocks of the operating table -As patient relaxes, trochar was passed through ant abd wall -Brisk bleeding was observed from the right abd trochar exit site -Bleeding was controlled by application of pressure by assistant Cystoscopy: intact bladder Left side was uneventful Anaesthetist noted drop of BP, corrected by IV fluids Zilbert et al. Int Urogyn J. 2001;12: 141 Canada

50. ComplicationPresentationSource External Iliac Artery Laceration Patient continued to bleed from right side & more uncomfortable Exploration of Rt abd incision, under GA, down to level of Fascia Figure-of-8 suture appeared to stop bleeding It was noted that when drapes were removed: patient unable to move her Rt leg BP at start 110/70 & at the end 90/60 Patient transfered to recovery Pre-operative Hb 12.7 gm, in recovery down to 2.4 gm Within next 20 min: patient unstable: BP 64/32, no pulse in in RT leg Zilbert et al. Int Urogyn J. 2001;12: 141 Canada

51. Complicatio n PresentationSource External Iliac Artery Laceration Return to theatre & exploration of Rt side abd incision: -Puncture of Rt ext iliac artery -Attempt to oversew the injury by Vascular Surgeon was unsuccessful -Resection & anastomosis of artery was successful -The tape on Rt side was cut -6 units of blood + FFP 48 hours in ICU 2 weeks in hospital 5 months FU: -Intermittent claudication Rt leg -Inguinal hernia -Persistent Urinary Incontinence Zilbert et al. Int Urogyn J. 2001;12: 141 Canada

52. How to Avoid Complications in TVT Muir et al. Obstet Gynecol 2003; 101:933 Empty Bladder Insert Bladder Catheter & Obturator “angled at 45 degree” TVT needle must be directed in close proximity to Posterior surface of Pubic bone Do not deviate lateral to Pelvic side wall Major vessels lie as close as 0.9 cm from Needle insertion site

53. How to Avoid Complications in TVT Muir et al. Obstet Gynecol 2003; 101:933 If Needle tip is TOO Cephalad to Pubic Bone → injury to: -Bladder -Bowel -Blood Vessel Keep TVT needle in a plane from: -Mid-Labia Majora toward -Ipsi-lateral Shoulder while -maintaining position directly behind Pubic Bone

54. How to Avoid Complications Use 70 Degree Cystoscope Tape must be placed with no tension “Tension-Free” Hyper-elevation: -Voiding dysfunction -Urinary retention -De Novo DI -Urethral Erosion Gap approximately 0.5 cm between Tape & Urethra My advice based on my own experience is: Cough Test in Theatre