LONG TERM FOLLOW UP OF THE TRANSOBTURATOR TAPE PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN A TERTIARY HOSPITAL IN SOUTH AFRICA

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1 LONG TERM FOLLOW UP OF THE TRANSOBTURATOR TAPE PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN A TERTIARY HOSPITAL IN SOUTH AFRICA Dr. A. Chrysostomou MD, FCOG (SA), Mmed (WITS) Senior Specialist, Dept O&G, Johannesburg Hospital

2 INTRODUCTION Stress Urinary Incontinence (SUI) is defined as the involuntary leakage of urine on effort or exertion or coughing without rise in detrusor pressure 1. It is estimated to affect up to one-third of women older than the age of 18-years, with a median age of 45 years 2. Tension-free vaginal tape (TVT) is a standard minimally invasive procedure used to treat SUI, introduced by Ulmsten in Years follow up 90% cure reported 4. Complications associated : bladder, bowel, vessel injuries as well as post operative VD (de novo urgency and UI) 5-11 The Transobturator approach introduced by Delorme in 2001 has been marked as safer due to avoidance of entry into the retropubic space 12

3 OBJECTIVES Evaluate : - The durability and long-term effectiveness of the transobturator tape (TOT) in the treatment of stress urinary incontinence and - The complications associated with TOT procedure and their management in our hospital setting

4 MATERIAL AND METHODS The study includes 120 women referred to the pelvic floor clinic with symptoms of SUI during the period April 2005 to April All the TOTs were performed at CMJAH and all cases were done by the same surgeon Urodynamic studies was not systematically performed Diagnosis of SUI was based on: History of SUI and Subjective complaints of involuntary leakage. Objective bedside investigations include: Positive cough test Post void residual volume of < 100ml Absence of urinary infection

5 The Procedure

6 THE PROCEDURE BASED ON DELORME DESCRIPTION

7 Insertion of the trocar or tunneller Incision at the level of genito-crural fold

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10 45 0 upwards and lateral to meet ischio-pubic rami Stay below fascia

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19 Postoperative evaluations Scheduled at 6 weeks, 6 months, 1 year thereafter yearly. Any patient with OAB symptoms or RV > 100 ml in absence of cystocele was referred for UDS Gynecological examination to exclude tape erosion 24 hour pad test was not performed Patients were considered to be objectively cured if they did not have SUI during the stress provocation test (cough test) Subjective success measured as the patient s satisfaction with the procedure Descriptive statistics showing the frequencies and percentages for categorical variables and means, standard variations and ranges for continuous variables were performed

20 RESULTS Procedures were performed under spinal anesthesia in 98 cases and under general anesthesia in 22 cases. 120 women underwent TOT during the study period, of which, 22 were associated with another surgical procedure. Time freezing was the end of April 2013 when the last patient who underwent TOT completed the 36 months follow-up The median follow up was 68 months (range months) ±5 years 8 months Of the original 120 women, 104(86,7%) where potentially available for follow up, either by protocol when they visited the clinic or by telephonic interview Subjective cure rates 90,4% Objective cure rates 93,4%

21 Patient s characteristicstot (n=120) Age (years) 54.7 ( 12.6) (29-87 years) Parity Mean 2.6 (P1-P6) Previous operations Anterior repair 14 Total abdominal hysterectomy 18 Vaginal Hysterectomy 10 PIVS 1 Concurrent operations during TOT procedures (n=22) Posterior IVS Vaginal hysterectomy LAVH Anterior repair Posterior repair Laparoscopic sterilization Removal of IUCD Removal of Labial cyst Laparoscopy cystectomy Fento s procedure

22 0 Frequency Parity Ageinyears Ageinyears Figure 1: Histogram of the Ages and the parity distribution across the ages. The condition appears in the parous woman with a peak at the age of 42 years, majority of the women had either two or three children.

23 Five different types of slings was used during the study period and are shown In table 2 Table 2 Transobturator mid-urethral slings entered into the study IVS-O Tyco 98 (81, 6%) Aris Mentor-Porges 16 (13, 3%) Monarc AMS 2(1, 6%) Obtryx Scientific 2 (1, 6%) Intramesh Cousin 2 (1, 6%)

24 Table 3 Intra-Operative Complications Bladder perforation 2 (1,6%) Vaginal perforation 2 (1, 6%) Bleeding > 100 ml 0 Urethral perforation 0 Others 0

25 Table 4 -Complications during follow-up Tape erosion 1 (0.8%) Sling failure 7 (5.8%) De novo UI 2 (1.6%)

26 DISCUSSION

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32 Discussion The results of this study show that the TOT is a simple, effective and safe procedure for treating SUI. The objective cure rate was 93,3% during the follow up period. There is a decreased risk of intra-operative complications with TOT s. There was no bleeding in our series as opposed to others vagina and 2 bladder perforation were recognised and corrected Bladder perforation is much less in MUS using obturator foramina, as compared to TVT. Cystoscopy not mandatory. Sub group analysis for bladder perforation found to be more often in TOT outside in group as compared to TVT-O Abdel Fatah et al (2006 ) reported 4 cases of urethra and bladder perforation in their series comparing TOT to TVT-O all of them allocated to TOT outside in technique. 3 of them was during the paraurethral tunnel creation and prior to tape insertion.

33 Long-term complications: Post-operative voiding problems (1.6%) were found to be less in our study, in agreement with other studies 25,29. 2 de Novo UI resolved with anti-colinergics 1 tape erosion found in our study, (0.8%) not in agreement with other studies that show erosion rates of 6.2% and 10% 19, failures (5.8%).4 cases (3.3%) objectively diagnosed and corrected by reinserting a new tape. 3 cases (2.5 %) subjective, not confirmed clinically or by UDS No urinary retention found in our study as opposed to others that show retention rate of 1.5% - 15% 19, 21.

34 Long term complications Post-operative groin or thigh complications, found in other studies 18,22 are not in agreement with the findings of this study. No groin or thigh complications noted. 14 women lost to follow up. Success rates from the women evaluated is representative of the performance of TOT procedure.

35 Conclusions The results from our study show that the TOT is a simple, effective and safe procedure for treating SUI. The procedure is comparable to other surgical techniques using the obturator fossa and avoiding the major risks of the retropubic approach All complications ( failure, erosion, VD ) were manifest in the first year of follow up The results are reassuring and show that there is no decline in efficacy of the TOT over time, even when we are dealing with aging population as 65% was older than 60 years of age

36 THANK YOU

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38 Guidelines for Surgery without UDS AHCPR, 2000

39 WHY URODYNANICS?

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42 Conservative (non surgical) treatment of SUI Simple life measures -Treatment of constipation -Treatment of chronic cough -Weight loss -Smoking cessation Physical therapy -Bio feed back -Electrical stimulation -PFMT

43 PFMT Short-term success 56-75% (Wilson et al. 1999, Hay-Smith et al. 2001) Compliance and motivation most important factors for success (Wilson et al. 1999) 15-20% approx. but better outcomes in those who comply (Hay-Smith et al. 2001)

44 Devices Vaginal Insufficient data to support -Ring pessary -Hodge -Tampon low 3rd of vagina - Vaginal cones similar effectiveness to PFMT Herbison P (CDSR) Urethral plugs increase efficacy lack patients acceptance (Miller 1996) Continue catheterization

45 Periurethral injections Bulking agents Subjective/Objective improvement 3 injections per year req d to achieve satisfactory results Cost Inferior to BURCH More studies needed Rickard 2006 (CDSR)

46 SURGICAL PROCEDURES BURCH CURE RATES VD DENOVO DI ENTEROCEL Retro public urethropexy (colposuspeusion) 85-90% 1yr 82% 5yrs 59-69% 10yrs 10,3% (2-27%) 17% (8-27%) 13,6% (2,5-26,7%) SUB URETHRA SLINGS TVT (prolene, ethical) Ulmsten mill Procedures Results consistent Improvements rates=burch 80-90% Less information about long term outcomes 86% with further 11% improvement 11% Is reported 3-23% Not as good as Burch, good as Kelly suture Clazener ,3% (short term) 3-15% UK NICE recommended that TVT may be used

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51 Rhabdosfincter Ω or horseshoe shape attached to bupocervical fascia Hammock like construction attached to pubic bone (tendinous arch)

52 Integral theory by Petros and Umsten lead to tension free tapes The use of mid urethral tapes based on integral theory is recreating support and stability between the urethra and the anterior vaginal wall.

53 Risk factors include: -Vaginal deliveries -Episiotomy not protective -Caesarian section -Ageing -Obesity -Constipation Aim of surgery is the stabilization and recreation of the backstop support.

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56 CONCLUSION

57 Epidemiology 10-40% more than 200 million women worldwide Pegay Norton 2006 From middle age onwards Reduce quality of life Corgos J Under reported Under treated

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59 Pathophysiology and Terminology Failure of the backstop support SUI Or neuromuscular compromise to the sphincter ISD The Hammock Hypothesis John O de Lancey 6

60 PETROS : Integral theory 7 of female incontinence Integral theory by Petros and Umsten lead to tension free tapes 8 The use of mid urethral tapes based on integral theory is recreating support and stability between the urethra and the anterior vaginal wall. Restoration of the hammock like support

61 Classification9

62 ASSESSMENT OF WOMEN WITH INCONTINENCE A. HISTORY SUI Initiating Factor + - OAB Frequency - + Nocturia - + Urgency - + Volume of Leakage Small Large Nature of leakage Spurts Steady stream Inclusion criteria Impaired bladder contractility on UDS present in 4 patients with overflow incontinence and 2 patients with mixed U.I Exclusion criteria UDS

63 TVT risk Bladder perforation 2.7%- 6% Haemorrhage 2.7% (0.8% reop) Bowel injury 0.3% - 0.7% Iliac vessels Deaths CURE RATES 86% with further 11% improvement Long term complications: Petros and Ulmsten Delorme VD 4.3% DI 3-15% Erosion 6% Laval 2003 TOT - O

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65 Transobturator tapes Delorme 2001 Success rates Complications Voiding DI TOT 85-97% Vag perforation Difficulties Outside in Small series Erosion ARIS F/U max 3yrs Bladder injury 1% Obtyx Groin pain Monarc IVS De Leval 2003 Success rate same TVT - O 85 95% MUT s not using obturator route TVT-secure system MINI-Arc with absorbable fixation tips until complete tissue in growth Minimal invasive No risk of obturator injury No groin skin incision No comparison studies

66 Suburethra slings TOT out/in Introduced by Delorme 2001 Avoid complications found with TVT High success rate Less complication Safety in terms of vessels and bladder perforation Less pain

67 Transobturator midurethral slings entered into the study IVS-O Tyco 98 (81.6%) Aris Mentor-Porges 16(13.3%) Monarc AMS 2 (1.6%) Obtryx Boston Scientific 2 (1.6%) Intramesh Cousin 2 (1.6%)

68 RESULTS All cases successfully completed Operation Time TOT only (n=98) TOT + Additional operations (n=22) Operation time(min) p< Hospital stay (days) 2.1 (2-3 days) TOT (n=120)

69 RESULTS TOT (n=57) Post operative pain as assessed by VAS Analgesia required Pethidine Day 1: 2.9 (0-5) Day 2: 1.06 (0-3) Day 1: 2.0 (1-3) Day 2: 1.1 (0-2)

70 Intraoperative Complications (n=120) Bladder perforation 2 (1.6%) Vaginal perforation 2 (1.6%) Bleeding 0 Urethral perforation 0 Others 0 Follow up: 1 week, 6 weeks, 6 months, 1 year and thereafter yearly Evaluation includes: cough stress test and vaginal examination. Residual volume if patient presents with OAB, UDS performed. 24 hour pad test was not done

71 Complications during follow-up Tape erosion 1 (0.8 %) Procedure Failure 3 (2.4%) De novo UI 1 (0.8%) UTI 4 Treated Successfully with antibiotics

72 Success Rates Figure 2 : Kaplan Meier Maintenance of Continence Kaplan-Meier survival estimate analysis time 120 (3) 106 (1) 74 (1) 50 (0) 38 (0) 22 (0) 7 (0) 0 Number at risk There were a total of five failures through out the 63 months of follow-up with a success rate of 94.5% and a cumulative total of five failures.