A Randomized Controlled Trial to Compare 2 Scalable Interventions for Lower Urinary Tract Symptom Prevention: Main Outcomes of the TULIP Study
Sampselle, Carolyn M., Diane K. Newman, Janis M. Miller, Keri Kirk, Mary Ann DiCamillo, Todd H. Wagner, Trivellore Raghunathan, and Ananias C. Diokno. 2017. "A Randomized Controlled Trial to Compare 2 Scalable Interventions for Lower Urinary Tract Symptom Prevention: Main Outcomes of the TULIP Study." The Journal of urology, 197(6): 1480-1486.
Purpose We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. Materials and Methods A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. Results A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. Conclusions The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women.
Population Health Methodology