Clinical Trial Follow‑Up Yields New Information on Surgery for Urinary Incontinence
A new report from a clinical trial comparing two surgeries to treat stress urinary incontinence (SUI) in women suggests that continued surveillance of outcomes is important in these patients. Women with SUI experience urine leakage under physical stress, such as coughing, laughing, sneezing, or lifting heavy objects. One treatment option for women with SUI is surgery to help prevent leakage; however, not much is known about how well different surgical approaches compare in terms of outcomes, both in the short and long term. The Trial Of Mid-Urethral Slings (TOMUS) study was conducted to compare the outcomes of two minimally invasive surgical sling procedures approved by the U.S. Food and Drug Administration to treat SUI in women. Both procedures use a synthetic mesh sling to support the urethra (the tube through which urine passes from the bladder to outside the body), thereby preventing urine leakage under stress; the procedures differ in how the mesh sling is inserted. In the trial, researchers randomly assigned nearly 600 women with SUI to either “retropubic” or “transobturator” midurethral sling surgery, and then compared rates of treatment success at 12 and 24 months post-operatively. The trial used two measures of treatment success: surgery was considered an objective success if women had no leakage during a stress test and 24 hour pad test, and also had no retreatment for SUI; it was considered a subjective success if women did not self-report SUI symptoms, leakage, or a need for retreatment.
Previously, researchers reported the one-year follow-up results from TOMUS, which showed that both procedures help women achieve similar levels of dryness as measured by objective success measures; self-reported outcomes, although similar, did not meet the trial criteria for equivalence.
Now, the researchers have reported that, after 24 months and a modest drop in success rates for both procedures, the two procedures are no longer equivalent by either success measure; however, the researchers did not ind clear enough differences between the success rates of the procedures to be able to recommend one procedure over another. Importantly, the TOMUS study also captured the risks and side effects of each type of surgery. For example, at 24 months, the group that underwent retropubic surgery had higher rates of voiding dysfunction requiring surgery, as well as more urinary tract infections; in contrast, women who had the transobturator surgery were more likely to experience neurological symptoms. Although the majority of adverse health events occurred in the irst 12 months post-surgery, onset of one serious complication, mesh exposure through a surgical incision site in the vaginal wall, differed in its timing between the two surgeries: its occurrence was more likely within 12 months of retropubic surgery, but within the 13 to 24 month period after transobturator surgery. Still, participant satisfaction with both surgical procedures remained high, with accompanying improvement in symptom severity and quality of life measures.
Overall, these new findings from the TOMUS study highlight the evolution of outcomes and the continued occurrence of complications over time, and therefore suggest that continued follow up is important in women who have mid-urethral sling surgery for SUI.