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Retropubic versus transobturator midurethral slings for stress incontinence.
N Engl J Med. 2010 Jun 03; 362(22):2066-76.NEJM

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 transobturator-sling 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.)

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave. South, Suite 10382, Birmingham, AL 35233, USA. hrichter@uabmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

20479459

Citation

Richter, Holly E., et al. "Retropubic Versus Transobturator Midurethral Slings for Stress Incontinence." The New England Journal of Medicine, vol. 362, no. 22, 2010, pp. 2066-76.
Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010;362(22):2066-76.
Richter, H. E., Albo, M. E., Zyczynski, H. M., Kenton, K., Norton, P. A., Sirls, L. T., Kraus, S. R., Chai, T. C., Lemack, G. E., Dandreo, K. J., Varner, R. E., Menefee, S., Ghetti, C., Brubaker, L., Nygaard, I., Khandwala, S., Rozanski, T. A., Johnson, H., Schaffer, J., ... Litman, H. J. (2010). Retropubic versus transobturator midurethral slings for stress incontinence. The New England Journal of Medicine, 362(22), 2066-76. https://doi.org/10.1056/NEJMoa0912658
Richter HE, et al. Retropubic Versus Transobturator Midurethral Slings for Stress Incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. PubMed PMID: 20479459.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR 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, AU - ,, Y1 - 2010/05/17/ PY - 2010/5/19/entrez PY - 2010/5/19/pubmed PY - 2010/6/12/medline SP - 2066 EP - 76 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 362 IS - 22 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 transobturator-sling 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.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/20479459/Retropubic_versus_transobturator_midurethral_slings_for_stress_incontinence_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa0912658?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -