Management of Urinary Stress Incontinence in KSA Tension-free Vaginal Tape Prof. Hassan Abduljabbar Dr. Hanan Al-Shamrani ,Dr.Sammeerah Basri. King Abdulaziz University Hospital ,Jeddah, Kingdom of Saudi Arabia Objective To review all cases of urinary stress incontinence treated with TVT at King Abdulaziz University Hospital Jeddah, Saudi Arabia . Study Design A prospective study using a standardized protocol for pre- and post- operative evaluation. Participants Thirty one women participated in the study All suffered from Genuine stress incontinence. The mean age 48 years ( SD 5 ) .All women were multiparous. Surgical Methods Tension-free vaginal tape implies the implantation of a prolene tape around the mid-urethra via a minimal vaginal incision .The procedure carried out under GA or local . . Results 28 women could be operated on under general anaesthesia,the other 3 were under regional (spinal).Only 3 cases took longer than 45 minutes in the operative time. 27 patients micturated spontaneously within 24 hrs with insignificant residual urine. 3 patients within 48 hours.One patient needed in-dwelling catheter for 5 days. . Conclusion TVT is safe , effective and fast surgical procedure for the treatment of female urinary stress incontinence . Can be done as day care case under local anesthesia. INTRODUCTION In 1990 Ulmsten proposed an integral theory, which challenged the current theories. He proposed that incontinence can be treated at the level of the mid urethra instead of the urethrovaginal junction (1, 3, and 5). The TVT procedure was started by Ulmsten in 1995 (2). The sling is made of a prolene mesh that is held in place by friction and not sutured to the anterior rectus fascia. The mesh is meant to only support the urethra and not to elevate it. With more than 500,000 procedures performed by June 2003, the TVT has become a widely used procedure in many countries to correct stress urinary incontinence. It is validated for patients with genuine stress incontinence with or without sphincteric deficiency providing there is some urethral hypermobility. This is a prospective study of a standardized tension –free tape technique. Using a special protocol for the evaluation of the outcome.the study was approved by the local ethics committee and all women gave an informed consent. METHODS Women diagnosed with primary urodynamic stress incontinence were recruited to the trial from the general gynecology clinic. Thirty one women participated in the study All suffered from Genuine stress incontinence. The mean age 48 years ( SD 5 ) .All women were multiparous. Women with detruser overactivity were excluded from the trial`.Patients specific data were collected prospectively from hospitalization until discharge.Patients were followed up at 1 month,3 months,6 months and 1 year from discharge. In the follow up stress provocation test was performed, and the patient was asked about her quality of life improvement. Patients were considered completely cured if the stress test was negative and the women indicated quality of life improvement more than 90%. Significantly improved patients are those with no incontinence on stress provocation test and quality of life satisfaction less than 90% but more than75%. Women who did not meet these criteria were considered failures. RESULTS All the surgeries were performed by a single surgical team .28 cases(90.3%) were performed under general anesthesia while in 3 cases(9.7%) regional anesthesia was used. Fig . 1. 30 28 25 20 15 10 3 5 0 General Figure. 1:TYPE OF ANAESTHESIA Regional In the majority of the cases the procedure was performed in (30-45) minutes with only 3 cases(9.7%) lasted more than 45 minutes .In these patients additional. surgeries in the form of anterior vaginal repair for correction of cystocele were performed. 25 20 15 10 5 0 0-15 15-30 30-45 45-60 60 Figure 1:Operative time There were no significant intra-operative complications or post-operative complications : no severe bleeding ≥250 mL., defective healing ,rejection of the tape , or bladder injuries except for one case of urinary retention that needed catheterization for 5 days. 27() women micturated spontaneously within 24 hours while 3() needed 48 hours.Fig.3. The patients were seen on the following intervals postoperatively one, three, six, and twelve months.There were one failure, 26 patients (84%) were cured and, 4 (12.9%) showed significant improvement. 30 27 25 20 15 10 5 3 1 0 24 hrs 48 hrs Figure 2:Post-op Voiding 5 days DISCUSSION The success rate in our study is high 96.9% total with 12.9% significant improvement and this is comparable to other studies done by Ulmsten et al 98 %(3)and Wang 86%(4) .In our study previous anterior repair did not affect the out come Table:1 Case series # of patients Ulmsten (7) 131 1998 Wang (6) 83 1998 Abduljabbar 31 2001 Previous procedure 0 Cure rate % 91% Significant Total improvement improvement 7% 98% 0 83% 3% 86% 26 84% 12.9% 96.9% Table.1.Total improvement rate Our results are in agreement with other reports using the same procedure table .2.In which they reported over all cure rate.The results in all these studies are in close agreement which indicate that the procedure is effective with reproducible cure rates. The use of general anesthesia instead of local or regional in our study is related to our population of patients were generally regional anesthesia is not well accepted. To overcome this gentle suprapubic pressure was used to adjust the placement of the tape without tension, and still we managed to get an acceptable success rate. The procedure lasted mostly between 30 and 40 minutes this includes the time of anesthesia, which is comparable to other studies. DATE AUTHOR COUNTRY 2001(19) 2000(13) 2000(14) 2000(15) 2000(16) 2000(17) 2000(12) 2000(18) 1999(11) 1999(10) 1999(9) 1999(8) 1998(7) 1998(9) 1998(6) LO WANG BASTA ET AL KLUTKE ET AL SOULIE ET AL JACQUETIN HALASKA JIMENEZ MALTAU PRIMICERIO GORDON OLSSON/KROON ULMSTEN NILSSON WANG TAIWAN TAIWAN POLAND UAS FRANCE FRANCE CZECH SPAIN NORWAY ITALY ISRAEAL SWEDEN SWEDEN FINLAND TAIWAN NO.OF PATIENTS 82 52 26 20 120 156 10 20 82 29 20 51 131 31 70 CURE RATE 93% 90% 92.31% 85% 86.7% 89.1% 100% 95% 96% 82% 95% 90% 90% n/a 83% Stanton (2004) conducted a literature review of all midurethral tape procedures and the studies conducted on each. The clinical studies were small in size and had short-term follow-up; thus, they cannot provide a statistically significant clinical comparison. Only one randomized clinical study has compared TVT with colposuspension. (20) The update (2005) consensus of the Sub-Committee on Urogynecology of the Society of Obstetricians and Gynecologists of Canada (SOGC). RECOMMENDATIONS: 1. The Burch procedure should be offered as the gold standard. The TVT procedure is promising but currently under evaluation in trials that will establish its efficacy and safety (II-3A). 2. Proper training is recommended prior to performing TVT procedures. 3. Long-term trial results are needed before the TVT procedure can be offered to patients as an equal alternative to the Burch procedure. (21) Conclusion TVT is safe, effective surgical procedure for the treatment of female urinary stress incontinence. Can be done as day care case under local anesthesia . References 1. Petros PE, Ulmsten U. An integral theory of female urinary incontinence. Acta Obstet Gynecol Scand 1990;69(suppl 153):1-79 2.U. Ulmsten and P. Petros, Intra vaginal sling plasty (IVS): an ambulatory surgicalprocedure for treatment of female urinary incontinence. Scand. J. Urol. Nephrol. 29 (1995), pp. 75–82. 3.Petros PE, Ulmsten U. Urethral and bladder neck closure mechanisms Am J Obstet Gynecol. 1994 Jun;170(6):1713-20 4.F. Haab, C. Ciofu and O. Traxer, The tension free vaginal tape technique: Why an unusual concept is so successful. Curr. Opin. Urol. 11 3 (2001), pp. 293– 297 5. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence 1996;7(2):81-5 6.Wang AC, Lo TS. Tension-free vaginal tape. A minimally invasive solution to stress urinary incontinence in women. J Reprod Med 1998;43: 429–434 7. Ulmsten U, Falconer C, Johnson P, et al. A multi-centre study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J 1998;9: 210–213 8. Olsson I, Kroon U-B. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Invest 1999;48: 267–269. 9. Gordon D, Groutz A, Lessing J. 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[Suspension of the lower third of the urethra in ambulatory practice--minimally invasive treatment of urinary stress incontinence--technique and initial experience Ceska Gynekol. 2000 Jan;65(1):4-9. 13.Wang AC An assessment of the early surgical outcome and urodynamic effects of the tension-free vaginal tape (TVT) Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(5):282-4. 14. Basta A, Pitynski K, Kolawa W Data from our recent trials with tension-free vaginal tape (TVT) procedure for surgical treatment of genuine urinary stress incontinence Ginekol Pol. 2000 Sep;71(9):1089-93. 15. Klutke JJ, Carlin BI, Klutke CG The tension-free vaginal tape procedure: correction of stress incontinence with minimal alteration in proximal urethral mobility Urology. 2000 Apr;55(4):512-4. 16. 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