Hypothesis / aims of study
Urgency urinary incontinence (UUI) significantly impacts quality of life. While pelvic floor muscle training (PFMT) and behavioral interventions are recommended as adjuncts to pharmacotherapy, comparative data focusing on patient-reported outcomes remain limited. This study aimed to compare the effects of PFMT versus structured behavioral interventions, both combined with pharmacotherapy, on quality of life and patient-reported improvement in women with UUI.
Study design, materials and methods
This is a secondary analysis of a randomized, open-label, pragmatic clinical trial. Sample size was calculated based on the primary outcome of the main trial (ICIQ-SF change), assuming a clinically meaningful difference of 3 points, standard deviation of 4, α=0.05, and 80% power, yielding 28 participants per group. To account for potential attrition, 40 participants were enrolled per group.
Eighty women with UUI were allocated 1:1 to pharmacotherapy plus PFMT (Group A, n=40) or pharmacotherapy plus structured behavioral interventions (Group B, n=40). The primary outcome for this analysis was the change in ICIQ-LUTSqol score from baseline to week 8. Secondary outcomes included Patient Global Impression of Improvement (PGI-I) and bladder diary parameters.
Between-group comparisons were performed using ANCOVA adjusted for baseline values. Analyses followed the intention-to-treat principle. Given the exploratory nature of this analysis, no adjustment was made for multiple comparisons. Ethical approval was obtained, and all participants provided written informed consent.
Interpretation of results
Both PFMT and structured behavioral interventions combined with pharmacotherapy resulted in clinically meaningful improvements in women with UUI. The greater improvement in quality of life observed with behavioral interventions, despite similar high rates of patient-reported global improvement, suggests additional benefits in patient-perceived disease burden. The moderate effect size (Cohen’s d=0.45) supports the clinical relevance of these findings. These results should be interpreted in the context of a secondary analysis.