Surgical, medical options offered similar outcomes for women with urinary incontinence
For patients with both stress and urgency urinary incontinence in whom conservative treatments and oral medications were unsuccessful, results were similar with onabotulinumtoxinA or a midurethral sling.
For women with mixed urinary incontinence that didn't respond to conservative treatment, onabotulinumtoxinA and a midurethral sling resulted in similar improvements in Urogenital Distress Inventory (UDI) score, a study found.
Researchers conducted a randomized superiority trial involving women who had moderate to severe bother from both stress and urgency urinary incontinence and had undergone unsuccessful conservative treatments and oral medications. The study was conducted at seven U.S. sites with enrollment from July 2020 to September 2022, with final follow-up December 2023. Patients received intradetrusor injection of onabotulinumtoxinA, 100 U (treatment focusing on the urgency component), or a surgical synthetic mesh midurethral sling (treatment focusing on the stress component). Recipients of onabotulinumtoxinA could receive an additional injection between three and six months, and all participants could receive additional treatment (including crossover to the alternative treatment) between six and 12 months. The primary outcome was change at six months in mixed incontinence symptoms as measured by the UDI total score (0 to 300 points with higher scores indicating worse symptoms; minimal clinically important difference, 26.1). Secondary outcomes included stress and irritative UDI subscores. Results were published by JAMA on May 5.
Among 150 women, 137 were treated, had postbaseline outcome data, and were included in the primary analysis (mean age, 59.0 years). Both treatment groups had a mean improvement in UDI total score at six months, with no significant difference between groups (−66.8 points [95% CI, −84.9 to −48.8 points] with onabotulinumtoxinA and −84.9 points [95% CI, −100.5 to −69.3 points] with a sling; mean difference, 18.1 points [95% CI, −4.6 to 40.7 points]; P=0.12). On the secondary outcomes, greater UDI stress score improvement was seen with the sling (−45.2 points; 95% CI, −53.7 to −36.8 points) than with onabotulinumtoxinA (−25.1 points; 95% CI, −34.1 to −16.1 points) (P<0.001). There was no significant difference between groups in UDI irritative score. By 12 months, 30.3% of patients in the sling group had received onabotulinumtoxinA and 15.5% of those in the onabotulinumtoxinA group had received a sling. Overall, adverse events did not differ between groups.
Given that there was no difference in UDI total score improvement at six months between the groups, the study indicates that treatment decisions can be based on patient preference in partnership with clinician recommendations, the study authors said.
“Moderate to severe bothersome stress and urgency incontinence can be difficult to treat with one therapy, as 22.6% received both a sling and onabotulinumtoxinA by 12 months,” they wrote. “These findings may help inform treatment decisions based on patient preference in partnership with clinician recommendations.”
An editorial agreed that both treatments can be offered to patients with mixed urinary incontinence. “Shared decision-making should ultimately guide therapeutic strategy,” the editorial stated. “Because 45% of patients had another therapy within a year, it underlines that mixed urinary incontinence is a chronic disease and may require new treatments over time.”