Figure 1. Screening, Randomization, Treatment, and Follow-up of Women Participating in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM) Trial.

^aIneligible participants are included in the adverse event analysis population. Randomized patients were determined to be ineligible during site audits based on invalid baseline bladder diaries, improper washouts from over active bladder medication, or Urogenital Distress Inventory scores.

^bParticipants without outcome data were included in the dichotomous re-treatment analysis and were conservatively assumed to have not been retreated.