Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

Holly E. Richter, Michael E. Albo, Halina M. Zyczynski, Kimberly Kenton, Peggy A. Norton, Larry T. Sirls, Stephen R. Kraus, Toby C. Chai, Gary E. Lemack, Kimberly J. Dandreo, R. Edward Varner, Shawn Menefee, Chiara Ghetti, Linda Brubaker, Ingrid Nygaard, Salil Khandwala, Thomas A. Rozanski, Harry Johnson, Joseph Schaffer, Anne M. Stoddard & 10 others Robert L. Holley, Charles W. Nager, Pamela Moalli, Elizabeth Mueller, Amy M. Arisco, Marlene Corton, Sharon Tennstedt, T. Debuene Chang, E. Ann Gormley, Heather J. Litman

Research output: Contribution to journalArticle

416 Citations (Scopus)

Abstract

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturatorsling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P = 0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P = 0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.).

Original languageEnglish (US)
Pages (from-to)2066-2076
Number of pages11
JournalNew England Journal of Medicine
Volume362
Issue number22
DOIs
StatePublished - Jun 3 2010

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Suburethral Slings
Retreatment
Confidence Intervals
Urge Urinary Incontinence
Therapeutics
Neurologic Manifestations
Exercise Test
Quality of Life

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Richter, H. E., Albo, M. E., Zyczynski, H. M., Kenton, K., Norton, P. A., Sirls, L. T., ... Litman, H. J. (2010). Retropubic versus Transobturator Midurethral Slings for Stress Incontinence. New England Journal of Medicine, 362(22), 2066-2076. https://doi.org/10.1056/NEJMoa0912658

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence. / Richter, Holly E.; Albo, Michael E.; Zyczynski, Halina M.; Kenton, Kimberly; Norton, Peggy A.; Sirls, Larry T.; Kraus, Stephen R.; Chai, Toby C.; Lemack, Gary E.; Dandreo, Kimberly J.; Varner, R. Edward; Menefee, Shawn; Ghetti, Chiara; Brubaker, Linda; Nygaard, Ingrid; Khandwala, Salil; Rozanski, Thomas A.; Johnson, Harry; Schaffer, Joseph; Stoddard, Anne M.; Holley, Robert L.; Nager, Charles W.; Moalli, Pamela; Mueller, Elizabeth; Arisco, Amy M.; Corton, Marlene; Tennstedt, Sharon; Chang, T. Debuene; Gormley, E. Ann; Litman, Heather J.

In: New England Journal of Medicine, Vol. 362, No. 22, 03.06.2010, p. 2066-2076.

Research output: Contribution to journalArticle

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', New England Journal of Medicine, vol. 362, no. 22, pp. 2066-2076. https://doi.org/10.1056/NEJMoa0912658
Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT et al. Retropubic versus Transobturator Midurethral Slings for Stress Incontinence. New England Journal of Medicine. 2010 Jun 3;362(22):2066-2076. https://doi.org/10.1056/NEJMoa0912658
Richter, Holly E. ; Albo, Michael E. ; Zyczynski, Halina M. ; Kenton, Kimberly ; Norton, Peggy A. ; Sirls, Larry T. ; Kraus, Stephen R. ; Chai, Toby C. ; Lemack, Gary E. ; Dandreo, Kimberly J. ; Varner, R. Edward ; Menefee, Shawn ; Ghetti, Chiara ; Brubaker, Linda ; Nygaard, Ingrid ; Khandwala, Salil ; Rozanski, Thomas A. ; Johnson, Harry ; Schaffer, Joseph ; Stoddard, Anne M. ; Holley, Robert L. ; Nager, Charles W. ; Moalli, Pamela ; Mueller, Elizabeth ; Arisco, Amy M. ; Corton, Marlene ; Tennstedt, Sharon ; Chang, T. Debuene ; Gormley, E. Ann ; Litman, Heather J. / Retropubic versus Transobturator Midurethral Slings for Stress Incontinence. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 22. pp. 2066-2076.
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abstract = "BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6{\%}) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8{\%} in the retropubic-sling group and 77.7{\%} in the transobturatorsling group (3.0 percentage-point difference; 95{\%} confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2{\%} and 55.8{\%}, respectively (6.4 percentage-point difference; 95{\%} CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7{\%} in those who received retropubic slings and 0{\%} in those who received transobturator slings (P = 0.004), and the respective rates of neurologic symptoms were 4.0{\%} and 9.4{\%} (P = 0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.).",
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T1 - Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

AU - Richter, Holly E.

AU - Albo, Michael E.

AU - Zyczynski, Halina M.

AU - Kenton, Kimberly

AU - Norton, Peggy A.

AU - Sirls, Larry T.

AU - Kraus, Stephen R.

AU - Chai, Toby C.

AU - Lemack, Gary E.

AU - Dandreo, Kimberly J.

AU - Varner, R. Edward

AU - Menefee, Shawn

AU - Ghetti, Chiara

AU - Brubaker, Linda

AU - Nygaard, Ingrid

AU - Khandwala, Salil

AU - Rozanski, Thomas A.

AU - Johnson, Harry

AU - Schaffer, Joseph

AU - Stoddard, Anne M.

AU - Holley, Robert L.

AU - Nager, Charles W.

AU - Moalli, Pamela

AU - Mueller, Elizabeth

AU - Arisco, Amy M.

AU - Corton, Marlene

AU - Tennstedt, Sharon

AU - Chang, T. Debuene

AU - Gormley, E. Ann

AU - Litman, Heather J.

PY - 2010/6/3

Y1 - 2010/6/3

N2 - BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturatorsling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P = 0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P = 0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.).

AB - BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturatorsling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P = 0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P = 0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.).

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