Evaluation of the effect of an online patient decision aid for female stress urinary incontinence: protocol for a stepped wedge study (the Decision study)

Abstract

Background Stress urinary incontinence (SUI) affects almost half of adult women and has a negative impact on quality of life. In the Netherlands, primary treatment options are pelvic floor muscle therapy (PFMT) and midurethral sling (MUS) surgery. This is a preference-based decision, in which the decision-making process may benefit from support from a patient decision aid (PDA). Use of a PDA overall reduces decisional conflict, the level of difficulty patients can experience when making a decision for a treatment or test. An online PDA for SUI treatment was developed to support the female SUI decision-making process. We hypothesize that use of the PDA will reduce decisional conflict. Methods The Decision study is a multicenter, prospective, stepped wedge study in which a group of patients who use the PDA is compared with controls. Eligible are women who have moderate to severe predominant SUI, did not give birth within the previous 6 months, do not wish to become pregnant anymore, do not have symptomatic vaginal prolapse, did not complete a course of PFMT within the last 6 months, have not undergone previous surgical SUI treatment and are able to use the internet in the Dutch language. Primary outcome is level of decisional conflict. Secondary outcomes are decisional regret, quality of life, urinary incontinence after treatment and the level of knowledge of the condition and treatment options. Questionnaires are filled in by patients after making the treatment decision and 6 months later. The study is powered for decisional conflict, with a 1:2 ratio of control-intervention group. A total of 366 patients is required, 122 in the control group and 244 in the intervention group. Discussion This study will evaluate the effect of the use of a PDA on the level of decisional conflict when making a decision for treatment in women with moderate to severe SUI. The outcomes will indicate whether implementation of the PDA in Dutch clinical practice will decrease decisional conflict. Trial registration number 2017-3540