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Randomized Controlled Trial
. 2011 Nov;205(5):498.e1-6.
doi: 10.1016/j.ajog.2011.07.011. Epub 2011 Jul 20.

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

Linda Brubaker  1 , Peggy A Norton, Michael E Albo, Toby C Chai, Kimberly J Dandreo, Keith L Lloyd, Jerry L Lowder, Larry T Sirls, Gary E Lemack, Amy M Arisco, Yan Xu, John W Kusek; Urinary Incontinence Treatment Network
Affiliations
Randomized Controlled Trial

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study

Linda Brubaker et al. Am J Obstet Gynecol. 2011 Nov.

Abstract

Objective: To describe surgical complications in 597 women over a 24-month period after randomization to retropubic or transobturator midurethral slings.

Study design: During the Trial of Midurethral Slings study, the Data Safety Monitoring Board regularly reviewed summary reports of all adverse events using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinicodemographic factors and surgical complications.

Results: A total of 383 adverse events were observed among 253 of the 597 women (42%). Seventy-five adverse events (20%) were classified as serious (serious adverse events); occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs 20 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups.

Conclusion: Adverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae.

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Conflict of interest statement

L.B., K.J.D., J.L.L., A.M.A., and J.W.K. report no conflict of interest.

References

    1. Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2009;(4):CD006375. - PubMed
    1. Latthe PM, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: A systematic review and meta-analysis of effectiveness and complications. BJOG. 2007;114(5):522–531. - PubMed
    1. Barber MD, Kleeman S, Karram MM, et al. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: A randomized controlled trial. Obstet Gynecol. 2008;111(3):611–621. - PubMed
    1. Albo ME. The trial of mid-urethral slings (TOMUS): Design and methodology. J Appl Res. 2008;8(1):1–13. - PMC - PubMed
    1. Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010;362(22):2066–2076. - PMC - PubMed

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