Diokno AC, et al. - Researchers performed this multisite randomized clinical trial (the GLADIOLUS study) to investigate the effectiveness, cost, and cost-effectiveness of group-administered behavioral treatment (GBT) vs no treatment for urinary incontinence (UI) in older women. Findings demonstrated the modest effectiveness and cost-effectiveness of a novel one-time GBT program for reducing UI frequency, severity, and bother, and improving quality of life in this patient population. The investigators suggested that access to noninvasive behavioral treatment could be improved via GBT in older women with UI.

Methods

• GLADIOLUS study was conducted from July 7, 2014, to December 31, 2016, at outpatient practices of three academic medical centers.
• Via mail, researchers recruited community-dwelling women aged ≥ 55 years with UI; screening for eligibility included a score of ≥ 3 on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), symptoms lasting ≥ 3 months, and absence of medical conditions or treatments that could affect continence status.
• Of mail respondents (n=2,171) and those who were invited for clinical screening (n-1,125), a total of 463 eligible participants were randomized, of whom 398 completed the 12-month study.
• They measured outcomes at in-person visits (3 and 12 months) and by mail or telephone (6 and 9 months).
• Change in the ICIQ-SF score was assessed as the primary outcome.
• UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs were assessed as the secondary outcome measures.
• Group assignment was not revealed to the evaluators.

Results

• Study participants included 232 women in the GBT group and 231 in the control group who were aged 55 to 91 years (mean [SD] age, 64 [7] years), of whom 46.2% were African American.
• The intent-to-treat analyses showed consistently lower ICIQ-SF scores for those in the GBT group vs those in the control group across all time points, but it did not achieve the projected 3-point difference.
• The difference in differences was 0.96 points (95% CI, −1.51 to −0.41 points) at 3 months, which was statistically significant but clinically modest.
• At 6, 9, and 12 months, the mean (SE) treatment effects were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively.
• Groups showed significant differences at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength.
• Treatment success was achieved at the incremental cost of $723 at 3 months; GBT dominated at 12 months.