Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Article
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

Abstract

Introduction and hypothesis

The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up.

Methods

This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O).

Results

The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 – 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 – 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse.

Conclusions

After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

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  CAS  PubMed  Google Scholar 

  2. 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 

  3. 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

    PubMed  Google Scholar 

  4. Kuuva N, Nilsson C (2002) A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 81:72–7

    Article  PubMed  Google Scholar 

  5. Flock F, Reich A, Muche R, Kreienberg R, Reister F (2004) Hemorrhagic complications associated with tension-free vaginal tape procedure. Obstet Gynecol 104:989–94

    Article  PubMed  Google Scholar 

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

    CAS  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. 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 

  9. Novara G, Galfano A, Boscolo-Berto R, Secco S, Cavalleri S, Ficarra V, Artibani W (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 

  10. Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ (2010) Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 362:2066–2076

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Schierlitz L, Dwyer PL, Rosamilia A, Murray C, Thomas E, De Souza A, Hiscock R (2012) 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 119:321–327

    Article  PubMed  Google Scholar 

  12. 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 

  13. 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 Pelvic Floor Dysfunct 21:779–785.

    Article  Google Scholar 

  14. Mostafa A, Lim CP, Hopper L, Madhuvrata P, Abdel-Fattah M (2014) 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 65:402–427

    Article  PubMed  Google Scholar 

  15. Masata J, Svabik K, Zvara K, Drahoradova P, El Haddad R, Hubka P, Martan A (2012) 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 23:1403–12

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

  17. Hubka P, Nanka O, Martan A, Svabik K, El-Haddad R, Masata J (2013) Fixation of the Ajust minisling based upon cadaveric study. Int Urogynecol J 24:2119–23

    Article  PubMed  Google Scholar 

  18. Hubka P, Masata J, Nanka O, Grim M, Martan A, Zvarova J (2009) Anatomical relationship and fixation of tension-free vaginal tape Secur. Int Urogynecol J Pelvic Floor Dysfunct 20:681–688

    Article  PubMed  Google Scholar 

  19. 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 

  20. Bump R, Mattiasson A, Bo K, Brubaker L, DeLancey J, Klarskov P, Shull B, Smith A (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17

    Article  CAS  PubMed  Google Scholar 

  21. Mostafa A, Agur W, Abdel-All M, Guerrero K, Lim C, Allam M, Yousef M, N'Dow J, Abdel-fattah M (2012) 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 165:115–121

    Article  PubMed  Google Scholar 

  22. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN (2010) 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 21:5–26.

    Article  Google Scholar 

  23. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P (2004) ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 23:322–330

    Article  PubMed  Google Scholar 

  24. Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP (1999) Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology 53:71–76

    Article  CAS  PubMed  Google Scholar 

  25. Abdel-Fattah M, Agur W, Abdel-All M, Guerrero K, Allam M, Mackintosh A, Mostafa A, Yousef M (2012) Prospective multi-centre study of adjustable single-incision mini-sling (Ajust((R)) ) in the management of stress urinary incontinence in women: 1-year follow-up study. BJU Int 109:880–886

    Article  PubMed  Google Scholar 

  26. Price DD, McGrath PA, Rafii A, Buckingham B (1983) The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain 17:45–56

    Article  CAS  PubMed  Google Scholar 

  27. Grigoriadis C, Bakas P, Derpapas A, Creatsa M, Liapis A (2013) 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 170:563–566

    Article  CAS  PubMed  Google Scholar 

  28. Schweitzer KJ, Milani AL, van Eijndhoven HW, Gietelink DA, Hallensleben E, Cromheecke GJ, van der Vaart CH (2015) Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial. Obstet Gynecol 125:27–34

    Article  PubMed  Google Scholar 

  29. Mostafa A, Agur W, Abdel-All M, Guerrero K, Lim C, Allam M, Yousef M, N'Dow J, Abdel-Fattah M (2013) 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. Urology 82:552–559

    Article  PubMed  Google Scholar 

  30. Abdel-Fattah M, Mostafa A, Familusi A, Ramsay I, N'Dow J (2012) Prospective randomised controlled trial of transobturator tapes in management of urodynamic stress incontinence in women: 3-year outcomes from the Evaluation of Transobturator Tapes study. Eur Urol 62:843–851

    Article  PubMed  Google Scholar 

  31. Naumann G, Steetskamp J, Meyer M, Laterza R, Skala C, Albrich S, Koelbl H (2013) Changes in sexual function and quality of life after single-incision mid-urethral sling for treatment of female stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol 168:231–235

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This work was supported by the Grant Agency of the Ministry of Health of the Czech Republic (grant NT 14162-3/2013).

Author information

Authors and Affiliations

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

    Jaromir Masata, Kamil Svabik, Petr Hubka & Alois Martan

  2. Faculty of Sciences, Charles University Prague, Prague, Czech Republic

    Karel Zvara

  3. 1st Faculty of Medicine, Charles University Prague, Prague, Czech Republic

    Ales Toman

Authors
  1. Jaromir Masata
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kamil Svabik
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Karel Zvara
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Petr Hubka
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ales Toman
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Alois Martan
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kamil Svabik.

Ethics declarations

Conflicts of interest

Jaromir Masata: None.

Kamil Svabik: consultant for Astellas.

Karel Zvara: None.

Petr Hubka: None.

Alois Martan: perceptor of Medicare, consultant for Astellas.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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 27, 1497–1505 (2016). https://doi.org/10.1007/s00192-016-3012-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00192-016-3012-x

Keywords

Search

Navigation