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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

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Abstract

Introduction and hypothesis

The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI).

Methods

This single-center 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 the evaluation of ICIQ-UI SH (when patients ticked “Never”/“Urine does not leak” in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented.

Results

One hundred ninety-seven women with proven SUI were randomized into three groups—TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02).

Conclusions

Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.

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References

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

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  Google Scholar 

  4. Karram M, Segal J, Vassallo B, Kleeman S (2003) Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 101:929–932

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

  6. Flock F, Reich A, Muche R, Kreienberg R, Reister F (2004) Hemorrhagic complications associated with tension-free vaginal tape procedure. Obstet Gynecol 104:989–994

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

  9. Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, Artibani W (2007) 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 52:663–678

    Article  PubMed  Google Scholar 

  10. Novara G, Galfano A, Boscolo-Berto R, Secco S, Cavalleri S, Ficarra V et al (2008) 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 53:288–308

    Article  PubMed  Google Scholar 

  11. Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT et al (2010) Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 362:2066–2076

    Article  PubMed  CAS  Google Scholar 

  12. Meschia M, Bertozzi R, Pifarotti P, Baccichet R, Bernasconi F, Guercio E et al (2007) Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O. Int Urogynecol J Pelvic Floor Dysfunct 18:1257–1261

    Article  PubMed  Google Scholar 

  13. Debodinance P (2007) 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 133:232–238

    Article  PubMed  Google Scholar 

  14. Neuman M (2008) Perioperative complications and early follow-up with 100 TVT-SECUR procedures. J Minim Invasive Gynecol 15:480–484

    Article  PubMed  Google Scholar 

  15. Liapis A, Bakas P, Creatsas G (2010) Comparison of the TVT SECUR System “hammock” and “U” tape positions for management of stress urinary incontinence. Int J Gynaecol Obstet 111:233–236

    Article  PubMed  Google Scholar 

  16. Krofta L, Feyereisl J, Velebil P, Otcenasek M, Kasikova E, Krcmar M (2010) TVT-S for surgical treatment of stress urinary incontinence: prospective trial, 1-year follow-up. Int Urogynecol J 21:779–785

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

  18. Larsson PG, Teleman P, Persson J (2010) A serious bleeding complication with injury of the corona mortis with the TVT-Secur procedure. Int Urogynecol J 21:1175–1177

    Article  PubMed  Google Scholar 

  19. Masata J, Martan A, Svabik K (2008) Severe bleeding from internal obturator muscle following tension-free vaginal tape Secur hammock approach procedure. International Urogynecology Journal 19:1581–1583

    Article  Google Scholar 

  20. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J et al (2010) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J 21:5–26

    Article  PubMed  Google Scholar 

  21. Martan A, Svabik K, Masata J, Koleska T, El-Haddad R, Pavlikova M (2009) Initial experience with a short, tension-free vaginal tape (the tension-free vaginal tape secur system). Eur J Obstet Gynecol Reprod Biol 143:121–125

    Article  PubMed  Google Scholar 

  22. Martan A, Svabik K, Masata J, Koleska T, El-Haddad R, Pavlikova M (2009) Correlation between changes in ultrasound measurements and clinical curative effect of tension-free vaginal tape-SECUR* procedure. International Urogynecology Journal 20:533–539

    Article  Google Scholar 

  23. Meschia M, Barbacini P, Ambrogi V, Pifarotti P, Ricci L, Spreafico L (2009) 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 20:313–317

    Article  PubMed  Google Scholar 

  24. Lee KS, Lee YS, Seo JT, Na YG, Choo MS, Kim JC et al (2010) 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 57:973–979

    Article  PubMed  Google Scholar 

  25. Lim JL, de Cuyper EM, Cornish A, Frazer M (2010) Short-term clinical and quality-of-life outcomes in women treated by the TVT-Secur procedure. Aust N Z J Obstet Gynaecol 50:168–172

    Article  PubMed  Google Scholar 

  26. Debodinance P, Amblard J, Lucot JP, Cosson M, Villet R, Jacquetin B (2009) TVT Secur: prospective study and follow up at 1 year about 154 patients. J Gynecol Obstet Biol Reprod (Paris) 38:299–303

    Article  CAS  Google Scholar 

  27. Andrada Hamer M, Larsson PG, Teleman P, Eten-Bergqvist C, Persson J (2011) Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur. Int Urogynecol J Pelvic Floor Dysfunct 22:781–787

    Article  Google Scholar 

  28. Tommaselli GA, Di Carlo C, Gargano V, Formisano C, Scala M, Nappi C (2010) 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 21:1211–1217

    Article  Google Scholar 

  29. Oliveira R, Botelho F, Silva P, Resende A, Silva C, Dinis P et al (2011) Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up. Eur Urol 59:940–944

    Article  PubMed  Google Scholar 

  30. Cornu JN, Sebe P, Peyrat L, Ciofu C, Cussenot O, Haab F (2010) Midterm prospective evaluation of TVT-Secur reveals high failure rate. Eur Urol 58:157–161

    Article  PubMed  Google Scholar 

  31. Hubka P, Masata J, Nanka O, Grim M, Martan A, Zvarova J (2009) Anatomical relationship and fixation of tension-free vaginal tape Secur. International Urogynecology Journal 20:681–688

    Article  Google Scholar 

  32. Hubka P, Nanka O, Martan A, Grim M, Zvarova J, Masata J (2011) TVT-S in the U position-anatomical study. Int Urogynecol J 22:241–246

    Article  PubMed  Google Scholar 

  33. Ridgeway BM, Arias BE, Barber MD (2008) Variation of the obturator foramen and pubic arch of the female bony pelvis. Am J Obstet Gynecol 198(546):e541–e544

    Google Scholar 

Download references

Acknowledgement

This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic, grant NS 10586-3/2009.

Conflicts of interest

Jaromir Masata, Kamil Svabik, Karel Zvara, Petra Drahoradova, Rachid El Haddad, and Petr Hubka have no conflicts of interest to declare. Alois Martan is a perceptor of Gynecare and Bard.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General Teaching Hospital, Prague, Czech Republic

    Jaromir Masata, Kamil Svabik, Petra Drahoradova, Rachid El Haddad, Petr Hubka & Alois Martan

  2. EuroMISE Center, Institute of Computer Science of the Academy of Sciences of the Czech Republic, Prague, Czech Republic

    Karel Zvara

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  1. Jaromir Masata
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  2. Kamil Svabik
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  7. Alois Martan
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Correspondence to Jaromir Masata.

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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 23, 1403–1412 (2012). https://doi.org/10.1007/s00192-012-1662-x

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