Comparison of quality of life of patients treated for SUI by surgical approaches AJUST and TVT-O – a 3-month results from randomized trial

Česká verzia

Authors: M. Smažinka ¹ ; K. Švabík ²; P. Hubka ² ; El. R. Haddad ²; J. Mašata ²
Authors place of work: Gynekologicko-porodnická klinika LF UK a FN, Plzeň, přednosta doc. MUDr. Z. Novotný, CSc. ¹; Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha, přednosta prof. MUDr. A. Martan, DrSc. ²
Published in the journal: Ceska Gynekol 2015; 80(3): 196-203

Summary

Objective:
The aim of this study is to compare quality of life in 3-month follow-up after the use of transobturator tape TVT-O and single incision tape AJUST in the treatment of urodynamic stress urinary incontinence (USI).

Design:
Randomized trial.

Setting:
Gynekologicko-porodnická klinika LF UK a FN Plzeň, Gynekologicko-porodnická klinika 1. LF UK a VFN Praha.

Materials and methods:
Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial. These patients were randomly chosen and devided into two group: 50 patients for TVT-O procedure and 50 patients for AJUST procedure. All of the patients underwent a complete urogynecological examination prior to the actual procedure (clinical examination, urodynamic examination, ultrasound examination) and filled in ICIQ-SF and iQol questionnaires. After the surgery, the patients satisfaction was evaluated by visual analoque scale (VAS) and Likert scale and by ICIQ-SF and iQol questionnaires. The intensity and length of postoperative pain was monitored using the visual analogue scale. The patients underwent an examination after 3 months.

Results:
In both groups of participants no significant differences regarding age, BMI, parity, history of surgery for gynecological disorders, were found. Preoperative urodynamic, ICIQ-SF and iQol parameters were also not significantly different. In the 3-month follow-up 48 participants from TVT-O group and 50 participants from the AJUST group were monitored. No statistically significant differences in subjective and objective parameters were found. Subjectively stress incontinence was not present in 97.9% in the TVT-O and 96.0% in the group AJUST. Objectively stress test was negative in 93.8% in the TVT-O and 94% in group AJUST. By evaluating the ICIQ and iQol were found no statistical differences in the quality of life in both operating groups.

Conclusion:
At 3-months follow up we did not find any statistical difference between subjective and objective outcome for single incision tape AJUST and TVT-O. In the AJUST group lower intensity and shorter duration of postoperative pain were observed.

Keywords:
TVT-O, AJUST, iQol, ICIQ, urodynamic stress urinary incontinence, Qaulity of life

Zdroje

1. Abdel-Fattah, M., Agur, W., Abdel-All, M., et al. Prospective multi-centre study of adjustace single-incision mini-sling (Ajust®) in the management of stress urinary incontinence in women: 1-year follow-up study. Int Urogynecol J, 2011, p. 880–886.

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

3. Boyles, S., Edwards, R., Greogory, W., Clark, A. Complications associated with trans-obturator sling procedures. Int Urogynecol J, 2007, 18(1), p. 19–22.

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

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

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

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

8. Drahorádová,M. Kvalita života po urogynekologických operacích. Praha: Disertační práce, 2011, s. 13-15.

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

10. Gobrecht, U., Kuhn, A., Fellman, B. Injury of the corona mores during vaginal tape insertion (TVT-Secur using the U-Approach). Int Urogynecol J, 2011, 22, p. 443–445.

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

12. Hubka, P., Nanka, O., Martan, A., et al. TVT-S in the U position-anatomical study. Int Urogynecol J, 2011, 22, p. 241–246.

13. Karram, M., Segal, J., Vassallo, B., Kleeman, S. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol, 2003, 101, 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, 2010, 21, 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, p. 72–77.

16. Larsson, PG., Teleman, P., Persson, J. A serious bleeding complication with injury of the corona mortis with the TVTSecurprocedure. Int Urogynecol J, 2010, 21, p. 1175–1177.

17. 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, p. 121–125.

18. Martan, A., a kol. Nové operační postupy v urogynekologii. Praha: Maxdorf, 2011, s. 79–83.

19. Mašata, J., Hubka, P., Martan, A. Pudendal neuralgia following transobturator inside-out tape procedure (TVT-O)—case report and anatomical study. Int Urogynecol J, 2011, p. 1555–1558.

20. Mašata, J., Martan, A., Švabík, K. Severe bleeding from internal obturator muscle following tension-free vaginal tape Secur hammock approach procedure. Int Urogynecol J, 2008, p. 1581–1585.

21. Mašata, J., Švabík, K., Hubka. P., Martan, A. Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment ofstress urinary incontinent women – 2-year follow-up. Int Urogynecol J, 2012, p. 1403–1412.

22. 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, p. 1257–1261.

23. Mostafa, A., Agur, W., Abdel-All, M., et al. Multicenter prospective randomized study of single-incision mini-sling vs tension-free vaginal tape-obturator in management of female stress urinary incontinence: a minimum of 1-year follow-up. Female Urology, p. 552–559.

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

25. Richter, H., Albo, M., Zyczynski, H., et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med, 2010, 362, p. 2066–2076.

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