Comparison of short term results of TVT-O and TVT-S in the surgical treatment of stress urinary incontinence

Česká verzia

Authors: J. Mašata ¹; K. Švabík ¹; K. Zvára ²; P. Drahodrádová ¹; P. Hubka ¹ ; R. Elhaddad ¹; A. Martan ¹
Authors place of work: Gynekologicko-porodnická klinika VFN a 1. LF. UK, Praha, přednosta prof. MUDr. A. Martan, DrSc. ¹; Euromise Centrum, Oddělení medicínské informatiky, Ústav informatiky Akademie věd ČR, Praha, ředitelka prof. RNDr. J. Zvárová, DrSc. ²
Published in the journal: Ceska Gynekol 2012; 77(4): 350-357

Summary

Objective of the study:
To compare short term results of tensionfree vaginal tape – obturator (TVT-O) and the tension free vaginal tape Seccure in the treatment of urodynamic stress urinary incontinence (USI).

Design:
Randomize trial.

Settings:
Department of Gynecology and Obstetrics, First Medical Faculty, Charles University; General Teaching Hospital, Prague.

Material and methods:
This single-centre randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire-Short form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on evaluation of ICIQ – UI SH (when patients ticked “Never” / “Urine does not leak” in answer to Question 6: When does urine leak?).

Results:
197 women with proved SUI were randomized into three groups – TVT-O (68), TVT-S H (64) and TVT-S U (65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in pre-operative characteristics. Three months after surgery were analyzed 65 women in TVT-O group, 61 in TVT-S H and 60 in TVT-S U. 95.4% subjects in the TVT-O group, 82% in the TVT-S H group and 76.7% in the TVT-S U group had stress test negative (p=0.006). 90.8% subjects in the TVT-O group, 82% in the TVT-S H group and 78.3% in the TVT-S U group were subjectively continent (NS).

Conclusions:
Our study demonstrated a significantly lower objective cure rate in the single incision TVT S group compared to the TVT-O group three months after surgery.

Key words:
stress urinary incontinence, TVT-O, TVT-S.

Zdroje

1. Andrada Hamer, M., Larsson, PG., Teleman, P., et al. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur. Int Urogynecol J Pelvic Floor Dysfunct, 2011, 22, 7, p. 781–787.

2. Cornu, JN., Sebe, P., Peyrat, L., et al. Midterm prospective evaluation of TVT-Secur reveals high failure rate. Eur Urol, 2010, 58, 1, p. 157–161.

3. de Leval, J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol, 2003, 44, 6, p. 724–730.

4. Debodinance, P. Trans-obturator urethral sling for the surgical correction of female stress urinary incontinence: outside-in (Monarc) versus inside-out (TVT-O). Are the two ways reassuring? Eur J Obstet Gynecol Reprod Biol, 2007, 133, 2, p. 232–238.

5. Debodinance, P., Amblard, J., Lucot, J P., et al. [TVT Secur: prospective study and follow up at 1 year about 154 patients]. J Gynecol Obstet Biol Reprod (Paris), 2009, 38, 4, p. 299–303.

6. Delorme, E. [Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women]. Prog Urol, 2001, 11, 6, p. 1306–1313.

7. Deng, D., Rutman, M., Raz, S., et al. Presentation and management of major complications of midurethral slings: Are complications under-reported? Neurourol Urodyn, 2007, 26, 1, p. 46–52.

8. Flock, F., Reich, A., Muche, R., et al. Hemorrhagic complications associated with tension-free vaginal tape procedure. Obstet Gynecol, 2004, 104, 5 Pt 1, p. 989–994.

9. Gobrecht, U., Kuhn, A., Fellman, B. Injury of the corona mortis during vaginal tape insertion (TVT-Secur using the U-Approach). Int Urogynecol J Pelvic Floor Dysfunct, 22, 4, p. 443–445.

10. Haylen, BT., de Ridder, D., Freeman, RM., et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J Pelvic Floor Dysfunct, 21, 1, p. 5–26.

11. Hubka, P., Nanka, O., Martan, A., et al. TVT-S in the U position-anatomical study. Int Urogynecol J Pelvic Floor Dysfunct, 22, 2, p. 241–246.

12. Hubka, P., Masata, J., Nanka, O., et al. Anatomical relationship and fixation of tension-free vaginal tape Secur. Int Urogynecol J, 2009, 20, 6, p. 681–688.

13. Karram, M., Segal, J., Vassallo, B., et al. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol, 2003, 101, 5 Pt 1, p. 929–932.

14. Krofta, L., Feyereisl, J., Velebil, P., et al. TVT-S for surgical treatment of stress urinary incontinence: prospective trial, 1-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct, 21, 7, p. 779–785.

15. Kuuva, N., Nilsson, C. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand, 2002, 81, 1, p. 72–77.

16. Larsson, PG., Teleman, P., Persson, J. A serious bleeding complication with injury of the corona mortis with the TVT-Secur procedure. Int Urogynecol J Pelvic Floor Dysfunct, 21, 9, p. 1175–1177.

17. Lee, KS., Lee, YS., Seo, JT., et al. A prospective multicenter randomized comparative study between the U- and H-type methods of the TVT SECUR procedure for the treatment of female stress urinary incontinence: 1-year follow-up. Eur Urol, 57, 6, p. 973–979.

18. Liapis, A., Bakas, P., Creatsas, G. Comparison of the TVT SECUR System “hammock” and “U” tape positions for management of stress urinary incontinence. Int J Gynaecol Obstet, 111, 3, p. 233–236.

19. Lim, JL., de Cuyper, EM., Cornish, A., et al. Short-term clinical and quality-of-life outcomes in women treated by the TVT-Secur procedure. Aust N Z J Obstet Gynaecol, 2010, 50, 2, p. 168–172.

20. Martan, A., Svabik, K., Masata, J., et al. Initial experience with a short, tension-free vaginal tape (the tension-free vaginal tape secur system). Eur J Obstet Gynecol Reprod Biol, 2009, 143, 2, p. 121–125.

21. Martan, A., Svabik, K., Masata, J., et al. Correlation between changes in ultrasound measurements and clinical curative effect of tension-free vaginal tape-SECUR* procedure. Int Urogynecol J, 2009, 20, 5, p. 533–539.

22. Masata, J., Martan, A., Svabik, K. Severe bleeding from internal obturator muscle following tension-free vaginal tape Secur hammock approach procedure. Int Urogynecol J, 2008, 19, 11, p. 1581–1583.

23. Meschia, M., Bertozzi, R., Pifarotti, P., et al. Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O. Int Urogynecol J Pelvic Floor Dysfunct, 2007, 18, 11, p. 1257–1261.

24. Meschia, M., Barbacini, P., Ambrogi, V., et al. TVT-secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multi-centre prospective trial. Int Urogynecol J Pelvic Floor Dysfunct, 2009, 20, 3, p. 313–317.

25. Neuman, M. Perioperative complications and early follow-up with 100 TVT-SECUR procedures. J Minim Invasive Gynecol, 2008, 15, 4, p. 480–484.

26. Nilsson, C., Falconer, C., Rezapour, M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol, 2004, 104, 6, p. 1259–1262.

27. Novara, G., Ficarra, V., Boscolo-Berto, R., et al. Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol, 2007, 52, 3, p. 663–678.

28. Novara, G., Galfano, A., Boscolo-Berto, R., et al. Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol, 2008, 53, 2, p. 288–308.

29. Ogah, J., Cody, DJ., Rogerson, L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn, 2011, 30, 3, p. 284–291.

30. Oliveira, R., Botelho, F., Silva, P., et al. Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up. Eur Urol, 2011, 59, 6, p. 940–944.

31. Ridgeway, BM., Arias, BE., Barber, MD. Variation of the obturator foramen and pubic arch of the female bony pelvis. Am J Obstet Gynecol, 2008, 198, 5, p. 546 e541–544.

32. Richter, HE., Albo, ME., Zyczynski, HM., et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med, 362, 22, p. 2066–2076.

33. Tommaselli, GA., Di Carlo, C., Gargano, V., et al. Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct, 2010, 21, 10, p. 1211–1217.

34. Ulmsten, U., Petros, P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol, 1995, 29, 1, p. 75–82.