Materials and Methods: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events.
Results: Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI !1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p¼0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p¼0.001), more negative impact on quality of life (p¼0.02) and worse sexual function (p¼0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p¼0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4).
Conclusions: Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However,
satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms
over time, although at a similarly low rate.
Authors: Kimberly Kenton, Anne M. Stoddard, Halina Zyczynski, Michael Albo, Leslie Rickey,k Peggy Norton, Clifford Wai, Stephen R. Kraus, Larry T. Sirls, John W. Kusek, Heather J. Litman, Robert P. Chang and Holly E. Richter
From Northwestern University, Chicago, Illinois (KK), New England Research Institutes, Watertown (AMS, RPC), and Boston Children’s Hospital, Boston (HJL), Massachusetts; University of Pittsburgh, Magee-Women’s Research Institute, Pittsburgh, Pennsylvania (HZ); University of California San Diego, San Diego, California (MA); Yale University, New Haven, Connecticut (LR); University of Utah, Salt Lake City, Utah (PN);University of Texas Southwestern, Dallas (CW), and University of Texas Health Sciences Center at San Antonio, San Antonio (SRK), Texas; William Beaumont Hospital, Royal Oak, Michigan (LTS); National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland (JWK); and University of Alabama at Birmingham, Birmingham, Alabama (HER) for the Urinary Incontinence Treatment Network)