Ultrasound comparison of adjustable single-incision (Ajust) and transobturator tapes to assess post-operative fixation and function and clinical efficacy

Česká verzia

Authors: F. Farhat ¹; K. Švabík ²; P. Hubka ² ; A. Martan ² ; J. Mašata ²
Authors place of work: Gynekologicko-porodnická klinika, Masarykova nemocnice, Ústí nad Labem, přednosta doc. MUDr. T. Binder, CSc. ¹; Gynekologicko-porodnická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. A. Martan, DrSc. ²
Published in the journal: Ceska Gynekol 2016; 81(5): 324-335

Summary

Objective:
The aim of this study was to compare fixation and mobility of adjustable single-incision (Ajust) and standard transobturator midurethral sling (TVT-O) tapes based on postoperative ultrasound monitoring of the position of the tape at rest and at maximal Valsava (tape descent). The hypothesis was that fixation of SIMS Ajust is comparable to that achieved by the standard transobturator midurethral sling.

Setting:
Gynecology and Obstetrics Department, GUH and 1st Charles University Prague; Gynecology and Obstetrics Department Masarykova nemocnice Ústí nad Labem.

Design:
Randomized trial, secondary analysis of ultrasound follow-up.

Methods:
Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial.

All patients underwent a complete urogynecological investigation before the procedure (clinical examination, urodynamics, ultrasound examination), and they filled in the ICIQ and iQol questionnaires; after surgery, to evaluate their satisfaction with the procedure, VAS and Likert scales were added.

Ultrasound examination as part of each post-operative check-up was performed the first day after surgery, two weeks, three months and one year after surgery. Ultrasound measurements were taken in a supine position at rest and during maximal Valsalva. Position of the bladder neck was assessed, and the position of the tape with respect to upper and lower tape margins.

Results:
At one-year follow up no differences in subjective cure rates and objective cure rates were observed. In all checks after surgery there was no difference between the position of the tape at rest and at maximal Valsalva between the Ajust and TVT-O groups.

The length of the upper and lower tape descent was similar. In TVT-O patients the mean length of upper tape margin descent increased from 8.8 mm on the first day after surgery to 10.0 mm three months after surgery; afterwards it remained stable. For Ajust patients there was virtually the same development – from 9.1 to 12 mm – and there was no further increase in the tape descent following the three-month measurement.

Conclusions:
The quality of the tape fixation after the Ajust procedure is as good as after standard transobturator midurethral sling. We did not observe any statistically significant differences in tape position and descent, indicating that the function is similar to obturator tape, which in turn suggests the same clinical efficacy. Ultrasound monitoring should be the part of post-operative monitoring whenever novel surgical techniques are introduced.

Keywords:
TVT-O, Ajust, iQol, ICIQ, stress urinary incontinence, transperineal utlrasound

Zdroje

1. Abdel-Fattah, M., Ford, JA., Lim, CP., et al. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications. Eur Urol, 2011, 60, 3, p. 468–480.

2. 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.

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. 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.

5. 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.

6. 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.

7. Grigoriadis, C., Bakas, P., Derpapas, A., et al. Tension-free vaginal tape obturator versus Ajust adjustable single incision sling procedure in women with urodynamic stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol, 2013, 170, 2, p. 563–566.

8. 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.

9. Hubka, P., Svabik, K., Martan, A., et al. A serious bleeding complication with injury of the corona mortis with the TVT-Secur procedure: two cases of contact of TVT-S with the corona mortis during cadaver study. Int Urogynecol J Pelvic Floor Dysfunct, 21, 9, p. 1179–1180.

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

11. 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.

12. Hubka, P., Masata, J., Nanka, O., et al. [Safety of TVT-O]. Ces Gynek, 2010, 75, 5, p. 471–473.

13. Hubka, P., Nanka, O., Martan, A., et al. TVT-S in the U position – anatomical study. Int Urogynecol J, 2011, 22, 2, p. 241–246.

14. Hubka, P., Nanka, O., Martan, A., et al. Anatomical study of position of the TVT-O to the obturator nerve influenced by the position of the legs during the procedure: based upon findings at formalin-embalmed and fresh-frozen bodies. Arch Gynecol Obstet, 2011, 284, 4, p. 901–905.

15. Hubka, P., Doumouchtsis, SK., Berger, MB., et al. Variation of distances from mid-urethra to the obturator foramen: an MRI study. Int Urogynecol J, 2012, 23, 8, p. 1075–1080.

16. Hubka, P., Nanka, O., Martan, A., et al. Fixation of the Ajust minisling based upon cadaveric study. Int Urogynecol J, 2013, 24, 12, p. 2119–2123.

17. 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.

18. 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.

19. 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.

20. Martan, A., Masata, M., Halaska, M. [Ultrasound examination of the lower urinary tract in women]. Ces Gynek, 1997, 62, 6, p. 350–352.

21. Martan, A., Masata, J., Halaska, M., et al. Ultrasound imaging of the lower urinary system in women after Burch colposuspension. Ultrasound Obstet Gynecol, 2001, 17, 1, p. 58–64.

22. Martan, A., Masata, J., Halaska, M., et al. Ultrasound imaging of paravaginal defects in women with stress incontinence before and after paravaginal defect repair. Ultrasound Obstet Gynecol, 2002, 19, 5, p. 496–500.

23. Martan, A., Masata, J., Svabik, K. [TVT SECUR System – tension-free support of the urethra in women suffering from stress urinary incontinence – technique and initial experience]. Ces Gynek, 2007, 72, 1, p. 42–49.

24. Martan, A., Masata, J., Svabik, K., et al. Curative effect of tension-free vaginal tape-secur* procedure-correlation with changes in ultrasound measurements. Int Urogynecol J, 2009, 20, 5.

25. 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 Gynec Reprod Biology, 2009, 143, 2, p. 121–125.

26. 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.

27. Martan, A., Krhut, J., Masata, J., et al. Prospective Randomized Study of MiniArc and Ajust Single Incision Sling Procedures. Low Urin Tract Symptoms, 2014, 6, 3, p. 172–174.

28. Masata, J., Svabik, K., Martan, A., et al. [What ultrasound parameter is optimal in the examination of position and mobility of urethrovesical junction?]. Ces Gynek, 2005, 70, 4, p. 280–285.

29. Masata, J., Martan, A., Svabik, K., et al. Ultrasound imaging of the lower urinary tract after successful tension-free vaginal tape (TVT) procedure. Ultrasound Obstet Gynecol, 2006, 28, 2, s. 221–228.

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

31. Masata, J., Martan, A., Svabik, K., et al. [Long-term efficacy of TVT procedure in the treatment of stress urinary incontinence]. Ces Gynek, 2009, 74, 2, p. 118–123.

32. Masata, J., Hubka, P., Martan, A. Pudendal neuralgia following transobturator inside-out tape procedure (TVT-O) – case report and anatomical study. Int Urogynecol J, 2012, 23, 4, p. 505–507.

33. Masata, J., Svabik, K., Zvara, K., et al. [Comparison of short term results of TVT-O and TVT-S in the surgical treatment of stress urinary incontinence]. Ces Gynek, 2012, 77, 4, p. 350–357.

34. Masata, J., Svabik, K., Zvara, K., et al. Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women – 2-year follow-up. Int Urogynecol J, 2012, 23, 10, p. 1403–1412.

35. Masata, J., Svabik, K., Martan, A. Bleeding complication with the TVT-Exact procedure: a report of two cases. Int Urogynecol J, 2015, 26, 2, p. 303–305.

36. Masata, J., Svabik, K., Zvara, K., et al. Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial. Int Urogynecol J, 2016,

37. Mostafa, A., Agur, W., Abdel-All, M., et al. A multicentre prospective randomised study of single-incision mini-sling (Ajust(R)) versus tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence: pain profile and short-term outcomes. Eur J Obstet Gynecol Reprod Biol, 2012, 165, 1, p. 115–121.

38. Mostafa, A., Lim, CP., Hopper, L., et al. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Eur Urol, 2014, 65, 2, p. 402–427.

39. 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.

40. 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.

41. 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.

42. 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.

43. Schierlitz, L., Dwyer, PL., Rosamilia, A., et al. Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency. Obstet Gynecol, 2012, 119, 2 Pt 1, p. 321–327.

44. Schweitzer, KJ., Milani, AL., van Eijndhoven, HW., et al. Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial. Obstet Gynecol, 2015, 125, 1, p. 27–34.

45. Smazinka, M., Svabik, K., Hubka, P., et al. [Comparison of quality of life of patients treated for SUI by surgical approaches AJUST and TVT-O – a 3-month results from randomized trial]. Ces Gynek, 2015, 80, 3, p. 196–203.

46. 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.

47. Ulmsten, U., Henriksson, L., Johnson, P., et al. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct, 1996, 7, 2, p. 81–85; discussion 85–86.