Diokno AC, et al. - This multisite, randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study) compared the effectiveness, cost, and cost-effectiveness of group-administered behavioral treatment (GBT) with no treatment for urinary incontinence (UI) in older women. Results showed that a one-time GBT program is modestly effective and cost-effective for decreasing UI frequency, severity, and bother, and improving patient quality of life. For older women with UI, GBT is a promising first-line approach to enhancing access to noninvasive behavioral treatment.

Methods

• This study was conducted from July 7, 2014, to December 31, 2016.
• Outpatient practices at three academic medical centers comprised the setting.
• Study participants were community-dwelling women aged ≥55 years with UI, and were enrolled via mail and screened for eligibility, which included a score of ≥3 on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), symptoms of ≥3 months’ duration, and absence of medical conditions or treatments that could affect continence status.
• A total of 1125 of 2171 mail respondents were invited for clinical screening; 463 were eligible and randomized, and 398 completed the 12-month study.
• For this analysis, the GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD.
• Researchers measured outcomes at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months).
• Change in ICIQ-SF score was the primary outcome.
• Secondary outcome measures included UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs.
• Evaluators were masked to group assignment.

Results

• Study participants (GBT group, n=232; control group, n=231) were aged 55 to 91 years (mean [standard deviation] age: 64 [7] years), and 46.2% (214/463) were African American.
• The ICIQ-SF scores for the GBT group were consistently lower versus the control group across all time points but did not achieve the projected three-point difference in intent-to-treat analyses.
• The difference in differences at 3 months was 0.96 points (95% confidence interval: -1.51 to -0.41), which was statistically significant but clinically modest.
• Findings revealed that the mean (standard error) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively.
• Apart from pelvic floor muscle strength, significant group differences were observed at all time points in favor of GBT on all secondary outcomes.
• The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months.