Figure 1. Enrollment, Randomization, and Analysis.

Of 517 patients who were assessed for eligibility, 337 were randomly assigned to receive a midurethral sling or sham incisions, 129 decided to participate in a patient-preference cohort, and 51 withdrew or did not meet eligibility requirements. Data from the women in the randomized and patient-preference cohorts were included in the intention-to-treat analyses.