A Randomized Controlled Trial of Consent for Patients Undergoing Transobturator Slings

Abstract

Importance Improving patients' recall and understanding of their planned surgery is essential for fully informed consent. Objective The objective of this study was to assess if the addition of an information handout to the standard preoperative consent process for the transobturator midurethral sling procedure improved patient understanding, recall, and satisfaction. Study Design This is a randomized controlled trial of adult women undergoing a transobturator midurethral sling procedure for the treatment of stress urinary incontinence. After standard counseling, participants were randomly assigned to either the control or the intervention group, with the latter receiving an extra informational handout detailing surgical information. Before surgery, all participants filled out a questionnaire assessing key points discussed during the surgical consent, which was used to calculate a knowledge score, the primary endpoint. Secondary outcomes included perception of the consent process and patient satisfaction. Results Of 98 randomized participants (50 control, 48 intervention), knowledge scores were 43% for controls and 57% for the intervention group (P = 0.015). Despite low scores, high self-rated understanding and satisfaction were noted across both groups (78% control, 71% intervention, P = 0.4). Notably, younger individuals, those with some college education, and patients undergoing additional prolapse surgery benefited most from the handout. Conclusions The informational handout improved knowledge scores, though overall knowledge scores were low in both groups. High satisfaction and perceived understanding of the planned procedure persisted, but the addition of a handout was not associated with a significant difference in knowledge scores.