Abstract
Introduction and hypothesis
This study compared transobturator tension-free vaginal tape (TVT-O®) and Contasure-Needleless (C-NDL®) at long-term follow-up .
Methods
Non-inferiority, prospective, single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL ® with transobturator vaginal tape (TVT-O®) mesh in the treatment of stress urinary incontinence (SUI) . Epidemiological information, intraoperative and postoperative complications, subjective estimates of blood loss and pain levels were recorded. We also analysed the postoperative stress test, the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) .
Results
Two hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O ® or C-NDL ® and were followed up at least 3 years after the procedure . One hundred and eleven women in the C-NDL ® group (84.7 %) had a negative stress test, compared with 54 women (88.9 %) in the TVT-O ® group (p = 0.0065 for the non-inferiority test). The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7 % of patients in the C-NDL ® group and 95.4 % of patients in the TVT-O ® group (p = 0.0022). The complication rate was similar in both groups. There were significant differences (p = 0.02) in postoperative pain within the TVT-O ® group. The degree of satisfaction was not statistically significant between the two groups.
Conclusions
The outcomes for the C-NDL ® group were similar to those of the TVT-O ® group, adding the concept of “single incision tape” to the tension-free sling option.
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References
Ulmsten U, Henriksson L, Johnson P, Varhos G (1996) An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 7:81–86
Ogah J, Cody JD, Rogerson L (2009) Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev (4) :CD006375. doi: 10.1002/14651858.CD006375.pub2
Cox A, Herschorn S, Lee L (2013) Surgical management of female SUI: is there a gold standard? Nat Rev Urol 10:78–89
Delorme E (2001) Trans-obturator urethral suspension: a minimally invasive procedure to treat female stress urinary incontinence. Progr Urol 11:1306–1313
Leval J (2003) Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out . Eur Urol 44:724–730
Kristensen I, Eldoma M, Williamson T et al (2010) Complications of the tension-free vaginal tape procedure for stress urinary incontinence. Int Urogynecol J 21:1353–1357
Lim J, Cornish A, Carey MP (2006) Clinical and quality of life outcomes in women treated by TVT-O procedure. BJOG 113:1315–1320
Collinet P, Ciofu C, Costa P et al (2008) The safety of the inside-out transobturator approach for transvaginal tape (TVT-O) treatment in stress urinary incontinence: French registry data on 984 women. Int Urogynecol J 19:712–715
Sivanesan K, Abdel-Fattah M, Ghani R (2007) External iliac artery injury during insertion of tension-free vaginal tape: a case report and literature review. Int Urogynecol J 18:1105–1108
Ballester M, Bui C, Frobert JL, Grisard-Anaf M, Lienhart J et al (2012) Four-year functional results of the suburethral sling procedure for stress urinary incontinence: a French prospective randomized multicentre study comparing the retropubic and transobturator routes. World J Urol 30:117–122
Serati M, Ghezz F, Cattoni E et al (2012) Tension-free vaginal tape for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 10-year follow-up . Eur Urol 61:939–946
Richter HE, Albo M, Zyczynski HM, Kenton K, Norton PA, for the Urinary Incontinence Treatment Network et al (2010) Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 362:2066–2076
Dyrkorn O, Kulseng-Hanssen O, Sandvik L (2010) TVT compared with TVT-O and TOT: results from the Norwegian National Incontinence Registry. Int Urogynecol J 21:1321–1326
Angioli R, Plotti F, Muzii L et al (2010) Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial. Eur Urol 58:671–677
Mostafa A, Chou PL, 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
Amat I Tardiu L, Martínez Franco E, Laïlla Vicens JM (2011) Contasure-Needleless® compared with transobturator-TVT® for the treatment of stress urinary incontinence. Int Urogynecol J 22:827–833
Espuña M, Rebollo P, Puig M (2004) Validación de la versión española del International Consulting on Incontinence Questionnaire-Short Form. Un cuestionario para evaluar la Incontinencia Urinaria. Med Clin 122:288–292
Sandvik H, Espuña M, Hunskaar S (2006) Validity of the incontinence severity index: comparison with pad-weighing tests. Int Urogynecol J 17:520–524
Ghoniem G, Stanford E, Kenton K et al (2008) Evaluation and outcome measures in the treatment of female urinary stress incontinence: International Urogynecological Association (IUGA) guidelines for research and clinical practice. Int Urogynecol J 19:5–33
Sung VW, Schleinitz MD, Rardin CR, Ward RM, Myers DL (2007) Comparison of retropubic vs transobturator approach to midurethral slings: a systematic review and meta-analysis . Am J Obstet Gynecol 197:3–11
Zullo MA, Plotti F, Calcagni M, Marullo E, Palaia I et al (2007) One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial. Eur Urol 51:1376–1382
Liapis A, Bakas P, Giner M, Creatsas G (2006) Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. Gynecol Obstet Invest 62:160–164
Porena M, Costantini E, Frea B, Giannantoni A, Ranzoni S, Maerini L et al (2007) Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: Results of a Multicentre Randomised Trial. Eur Urol 52:1481–1490
Mora I, Amat Tardiu L, Martínez E, Lailla JM (2007) Analysis of efficacy and complications in the surgical treatment of stress urinary incontinence: experience with retropubic and transobturator TVT®. Arch Esp Urol 60:1091–1098
Waltregny D, Gaspar Y, Reul O, Hamida W, Bonnet P, De Leval J (2008) TVT-O for the treatment of female stress urinary incontinence: results of a prospective study after a 3-year minimum follow-up . Eur Urol 53:401–408
Haliloglu B, Rizk DE (2010) Subjective versus objective measurement of surgical outcomes of treatment of female stress urinary incontinences: it is not just black and white. Int Urogynecol J 21:761–762
Brubaker L, Norton PA, Albo ME, for the Urinary Incontinence Treatment Network et al (2011) Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol 205(498):e1–e6
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We are grateful to Jaume Aguado for statistical support.
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Martinez Franco, E., Amat Tardiu, L. Contasure-Needleless® single incision sling compared with transobturator TVT-O ® for the treatment of stress urinary incontinence: long-term results. Int Urogynecol J 26, 213–218 (2015). https://doi.org/10.1007/s00192-014-2475-x
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DOI: https://doi.org/10.1007/s00192-014-2475-x