Adverse events over two years after retropubic or transobturator midurethral sling surgery

Findings from the Trial of Midurethral Slings (TOMUS) study

Linda Brubaker, 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

Research output: Contribution to journalArticle

101 Citations (Scopus)

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.

Original languageEnglish (US)
JournalAmerican Journal of Obstetrics and Gynecology
Volume205
Issue number5
DOIs
StatePublished - Nov 2011

Fingerprint

Suburethral Slings
Clinical Trials Data Monitoring Committees
Logistic Models
Random Allocation
Nervous System
Urinary Bladder

Keywords

  • adverse events
  • midurethral slings
  • surgical complications

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Adverse events over two years after retropubic or transobturator midurethral sling surgery : Findings from the Trial of Midurethral Slings (TOMUS) study. / Brubaker, Linda; Norton, Peggy A.; Albo, Michael E.; Chai, Toby C.; Dandreo, Kimberly J.; Lloyd, Keith L.; Lowder, Jerry L.; Sirls, Larry T.; Lemack, Gary E.; Arisco, Amy M.; Xu, Yan; Kusek, John W.

In: American Journal of Obstetrics and Gynecology, Vol. 205, No. 5, 11.2011.

Research output: Contribution to journalArticle

Brubaker, Linda ; Norton, Peggy A. ; Albo, Michael E. ; Chai, Toby C. ; Dandreo, Kimberly J. ; Lloyd, Keith L. ; Lowder, Jerry L. ; Sirls, Larry T. ; Lemack, Gary E. ; Arisco, Amy M. ; Xu, Yan ; Kusek, John W. / Adverse events over two years after retropubic or transobturator midurethral sling surgery : Findings from the Trial of Midurethral Slings (TOMUS) study. In: American Journal of Obstetrics and Gynecology. 2011 ; Vol. 205, No. 5.
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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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