Diokno AC, et al. - In older women, authors compared the efficacy, cost, and cost-effectiveness of one-time group-administered behavioral treatment (GBT) with no treatment for urinary incontinence (UI). Modest effectiveness and cost-effectiveness of this GBT program in reducing UI frequency, severity, and bother and improved quality of life was seen in the GLADIOLUS study. In order to enhance access to noninvasive behavioral treatment for older women with UI, group-administered behavioral treatment is encouraging as a first-line approach.

Methods

• Experts conducted a multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), from July 7, 2014 to December 31, 2016.
• Settings included outpatient practices at 3 academic medical centers.
• They recruited the community-dwelling women 55 years or older with UI by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), symptoms of at least 3 months’ duration, and absence of medical conditions or treatments that could affect continence status.
• Of 2,171 mail respondents, they invited 1,125 for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study.
• A one-time 2-hour bladder health class, supported by written materials and an audio CD was received by the GBT group.
• Researchers measured the outcomes at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months).
• The change in the ICIQ-SF score was the primary outcome.
• UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs were assessed by secondary outcome measures.
• They masked the evaluators to group assignment.

Results

• Participants (232 in the GBT group and 231 in the control group) were 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American.
• As per data, the ICIQ-SF scores in intent-to-treat analyses for GBT were consistently lower than controls across all time points, but did not achieve the projected 3-point difference.
• The difference in differences at 3 months was 0.96 points (95% CI, −1.51 to −0.41 points), 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.
• At all time points, significant group differences were found in favor of GBT on all secondary outcomes except pelvic floor muscle strength.
• A total of $723 at 3 months is the incremental cost to achieve a treatment success; GBT dominated at 12 months.