Top

International Urogynecology Journal

Published in:

01-07-2011 | Original Article

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur

Authors: Maria Andrada Hamer, Per-Göran Larsson, Pia Teleman, Christina Etén-Bergqvist, Jan Persson

Published in: International Urogynecology Journal | Issue 7/2011

Abstract

Introduction and hypothesis

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.

Methods

We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.

Results

No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).

Conclusions

In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

Norton P, Brubaker L (2006) Urinary incontinence in women. Lancet 367:57–67PubMedCrossRef

Hunskaar S, Lose G, Sykes D, Voss S (2004) The prevalence of urinary incontinence in women in four European countries. BJU Int 93:324–330PubMedCrossRef

Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjälmås K, Lapitain MC (2003) Epidemiology and natural history of urinary incontinence in women. Urology 62(Suppl 4):16–23PubMedCrossRef

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 Pelvic Floor Dysfunct 7:81–86PubMedCrossRef

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

Ward KL, Hilton P, UK and Ireland TVT Trial Group (2004) A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 190:324–331PubMedCrossRef

Ogah J, Cody JD, Rogerson L(2009) Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev.CD006375

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 362:2066–2076PubMedCrossRef

Daneshgari F, Kong W, Swartz M (2008) Complications of mid urethral slings: important outcomes for future clinical trials. J Urol 180:1890–1897PubMedCrossRef

10.

Persson J, Eten Bergqvist C, Wølner-Hanssen P (2001) An ultra-short perineal pad-test for evaluation of female stress urinary incontinence treatment. Neurourol Urodyn 20:277–285PubMedCrossRef

11.

Neuman M (2007) TVT-Secur: 100 teaching operations with a novel anti-incontinence procedure. Pelviperineology 26:121–127

12.

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 Pelvic Floor Dysfunct 21(9):1175–1177 [PMID 20179906]PubMedCrossRef

13.

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. doi:20206437

14.

Khandwala S, Jayachandran C, Sengstock D (2010) Experience with TVT-SECUR sling for stress urinary incontinence: a 141-case analysis. Int Urogynecol J Pelvic Floor Dysfunct 21:767–772PubMedCrossRef

15.

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

16.

Sola V, Ricci P, Pardo J (2009) Third generation sub-mid urethral mesh: experience with 110 TVT-Secur. Arch Esp Urol 62:376–388PubMedCrossRef

17.

Tartaglia E, Delicato G, Baffigo G, Signore S, Corvese F, Perla A et al (2009) Third generation tension-free tape for female stress incontinence. J Urol 182:612–615PubMedCrossRef

18.

Oliveira R, Silva A, Pinto R, Silva J, Silva C, Guimarães M et al (2009) Short-term assessment of a tension-free vaginal tape for treating female stress urinary incontinence. BJU Int 104:225–228PubMedCrossRef

19.

Jiménez Calvo J, Hualde Alfaro A, Raigoso Ortega O, Cebrian Lostal JL, Alvarez Bandres S, Jiménez Parra J et al (2008) Our experience with mini tapes (TVT Secur and MiniArc) in the surgery for stress urinary incontinence. Actas Urol Esp 32:1013–1018PubMedCrossRef

20.

Martan A, Svabík K, Masata J, Koleska T, El-Haddad R, Pavlikova M (2008) The solution of stress urinary incontinence in women by the TVT-S surgical method. Correlation between the curative effect of this method and changes in ultrasound findings. Ces Gynekol 73:271–277

21.

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 Gynécol Obstét Biol Reprod 38:299–303CrossRef

22.

Martan A, Svabík 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. Int Urogynecol J Pelvic Floor Dysfunct. doi:19219379

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 20:313–317PubMedCrossRef

24.

Cornu JN, Sèbe P, Peyrat L, Ciofu C, Cussenot O, Haab F (2010) Midterm prospective evaluation of TVT-secur reveals high failure rate. Eur Urol. doi:20434258

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 50:168–172PubMedCrossRef

26.

Krofta L, Feyereisl J, Velebil P, Otcenásek M, Kasíková E, Krcmár M (2010) TVT-S for surgical treatment of stress urinary incontinence: prospective trial, 1-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct 21:779–785PubMedCrossRef

27.

Delmas V, Villet R, Debodinance P, Fernandez H, Jacquetin B, Haab F (2008) Where are the extremities of the TVT Secur? Eur Urol Suppl 7:148CrossRef

28.

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 20:681–688PubMedCrossRef

29.

Hubka P, Svabik K, Martan A, Masata J (2010) 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 21:1179–1180PubMedCrossRef

30.

Masata J, Martan A, Svabík K (2008) Severe bleeding from internal obturator muscle following tension-free vaginal tape Secur hammock approach procedure. Int Urogynecol J Pelvic Floor Dysfunct 19:1581–1583PubMedCrossRef

31.

Roth TM (2009) An unexpected case of dyspareunia and partner dyspareunia following TVT-Secur. Int Urogynecol J Pelvic Floor Dysfunct 20:1391–1392PubMedCrossRef

Title: Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur
Authors: Maria Andrada Hamer
Per-Göran Larsson
Pia Teleman
Christina Etén-Bergqvist
Jan Persson
Publication date: 01-07-2011
Publisher: Springer-Verlag
Published in: International Urogynecology Journal / Issue 7/2011
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-011-1381-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 7/2011

Laparoendoscopic single-site (LESS) sacrocolpopexy: feasibility and efficacy of knotless procedure performed with conventional instruments

Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known

Is there a pelvic organ prolapse threshold that predicts bladder outflow obstruction?

The help-seeking by women with urinary incontinence in Brazil

Basic science and clinical aspects of mesh infection in pelvic floor reconstructive surgery

Does concomitant prolapse repair at the time of midurethral sling affect recurrent rates of incontinence?