Introduction

Primary aim: to compare the effectiveness and safety of a group-administered behavioral treatment program (GBT) to no treatment in older women with stress, urgency, or mixed urinary incontinence (UI). _x000D_

Methods

Recruitment letters were mailed to women 55 years and older at three sites (Alabama, Michigan & Pennsylvania) seeking UI naïve to previous therapy. Responders were screened by phone and eligible respondents were referred to sites for clinical screening and randomization. Inclusion/exclusion criteria included age 55+, International Consultation on Incontinence questionnaire (ICIQ-SF) score at least 3 (1 for frequency, 2 for severity), minimum 3-months duration, no prolapse, previous bladder surgery or pelvic cancers. Primary outcome: ICIQ-SF. Secondary outcomes: 3-day voiding diary (VD), paper towel test, 24-hr pad test, Brink test, Patient Global Impression of Improvement (PGI-I) and other UI questionnaires. GBT group received a one-time 2-hour bladder health class whereas control received usual care. Both received behavioral education brochure, monitored every 3 months for 12-months; clinic visits at 3 & 12 months and mailed questionnaires at 6 & 9 months._x000D_

Results

463 subjects were randomized to GBT (232) or control (231). 34 withdrew (GBT=22 & Control =12). Demographics were not significantly different between groups. Outcomes at 3, 6, 9 & 12 months showed significant differences in favor of GBT over control including ICIQ (p<0.0001) (Fig 1), # leaks @ VD (p0.0002), paper towel test (p0.0008), 24-hr pad weights (p0.0007), Medical, Epidemiologic & Social aspects of Aging questionnaire (MESA) (p<0.0001), Incontinence Quality of Life (IQOL) (p<0.0001) & PGI-I (p<0.0001) but not the Brink test for pelvic floor strength (p0.09-.9). No significant difference in adverse events or serious events were encountered in each group. (all p values at 12 months) _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_ _x000D_

Conclusions

This novel GBT bladder health education program was safe & effective in reducing UI frequency, severity and bother and improving quality of life for older women with UI in the community. This easily scaled intervention increases opportunity to reach larger populations beyond clinical into community settings. _x000D_

Funding

NIH/NIA # RO1AG043383