Hypothesis / aims of study
Over a third of midlife and older women experience urinary incontinence (UI), but less than half of women with UI are actively engaged in treatment. Due to the limitations of existing clinical treatments, many women with UI are interested in identifying alternative management strategies that are not only effective but better tolerated and more accessible. Pelvic yoga has been recommended as a complementary behavioral management strategy for UI, but there has been almost no study of its efficacy or safety in women across the aging spectrum, nor comparison to other more general physical activity-based interventions. The Lessening Incontinence with Low-impact Activity (LILA) trial was designed to evaluate the effects of a group-based pelvic yoga program versus a non-specific physical conditioning program among ambulatory midlife and older women with at least daily UI.
Study design, materials and methods
The LILA trial is a multisite randomized trial of a group-based therapeutic yoga program designed by a multidisciplinary panel of yoga and clinician experts to improve pelvic floor strength, peripheral autonomic function, and overall physical function as factors contributing to bladder control in ambulatory women across the aging spectrum. Women aged 45 or older who reported urgency-predominant, stress-predominant, or mixed stress-and urgency-type UI occurring on least a daily basis but could walk one block on level ground unassisted were recruited from the general community surrounding three clinical study sites in the United States in 2019-2022. Eligible participants were randomly assigned to a therapeutic yoga program consisting of twice weekly group instruction by trained instructors and once weekly individual practice of study-specific Hatha yoga techniques tailored for 3 months, versus a non-specific physical conditioning program involving equivalent-time group instruction and individual practice of general upper and lower extremity stretching/strengthening exercises. Prior to the COVID-19 pandemic, group intervention classes were conducted in person in brick-and-mortar yoga or exercise studios; after March 2020, group intervention instruction was converted to a commercially available videoconference platform. Changes in any-type and type-specific UI were assessed by validated 3-day voiding diaries abstracted by blinded analysts. Linear mixed models examined change in frequency of any-type UI over 3 months (primary outcome) as well as urgency- and stress-type UI over 3 months (secondary outcomes), controlling for study site and intervention class.
Results
Of the 240 participants randomized (121 yoga, 119 physical conditioning), mean age was 62.0 (±8.7) years (total age range 45 to 90 years), and 40% self-identified as ethnic minorities (14% Latina/Hispanic, 6% Black/African American, 16% Asian/Asian American, 4% multiracial). At baseline, participants reported an average of 3.4 (±2.2) UI episodes/day, including 1.9 (±1.9) urgency-type and 1.4 (±1.7) stress-type UI episodes/day. Over 3 months, total UI frequency decreased an average of 75% from baseline (2.4 episodes/day) in the yoga versus 58% (1.8 episodes/day) in the physical conditioning group (between-group difference of 0.5 episodes/day [95%CI 0.0-1.1] in favor of the yoga group, P=.04). Urgency UI frequency decreased by 80% (1.2 episodes/day) in the yoga versus 54% (0.8 episodes/day) in the physical conditioning group (between-group difference of 0.4 episodes/day [95%CI 0.1-0.8] in favor of the yoga group, P=.02). Reductions in stress-type UI frequency did not differ significantly by group (70% in yoga and 65% in physical conditioning group (between-group difference of -0.1 episodes/day [95%CI -0.2, 0.4]; P=.61). Over 3 months, 13% of yoga and 15% of physical conditioning participants reported mild musculoskeletal adverse events (P=.67); no serious adverse events were associated with yoga instruction.
Interpretation of results
Among ambulatory midlife and older women with at least daily urgency-, stress, or mixed-type UI, a group-based pelvic yoga intervention was associated with a 75% decrease in all-type UI frequency over 3 months, although lesser but still meaningful improvements were also observed with an equivalent-time non-specific physical conditioning intervention.