1R34AT008028 PI: Huang, Alison Revised Abstract Over 20 million women in the United States suffer from urinary incontinence, a condition leading to depression, social isolation, functional decline, and loss of ability to live independently. First-line treatment for incontinence consists of behavioral management strategies such as pelvic floor muscle exercises that are difficult for women to lean to practice effectively in course of routine care. Second-line treatments have problematic side effects or other limitations that decrease their safety and accessibility, particularly for older women who are at greatest risk of developing incontinence. As a result, alternate treatment strategies are needed that are not only effective but also more accessible and better tolerated. Yoga is a complementary behavioral intervention with the potential to improve bladder control through multiple mechanisms. When practiced in a way that emphasizes mindful awareness of specific bodily structures, yoga can be used to increase womens control over their pelvic floor muscles, improve their autonomic nervous system balance, and decrease underlying stress and anxiety, all of which may alleviate incontinence. To explore the preliminary efficacy and safety of yoga to treat incontinence, our research team developed a structured, group-based yoga therapy program involving twice weekly group yoga classes supplemented by once weekly home yoga practice. In a pilot trial of ambulatory middle-aged and older with frequent stress, urgency, or mixed incontinence, women randomized to this yoga therapy program showed on over 50% greater reduction in incontinence frequency relative to a waitlist control. We now propose to conduct an R34-scale pilot study to test and refine procedures for a more rigorous, full-scale efficacy trial of yoga for treatment of incontinence in middle-aged and older women. We will randomize at least 50 ambulatory middle-aged and older women with urgency, stress, or mixed-type incontinence to take part in either a group-based yoga therapy program or a time-equivalent stretching/strengthening exercise control program. Using data collected over 12 weeks of treatment and 12 weeks of post-treatment follow-up, we will examine the feasibility of recruiting and retaining ambulatory middle-aged and older women in this trial design, collect preliminary data on the effects of the yoga intervention on incontinence and related quality-of-life outcomes, and explore potential differences in treatment efficacy by duration of treatment and follow-up.
The proposed clinical trial will provide rigorous evidence of the efficacy and safety of a group-based yoga therapy intervention to enhance usual first-line behavioral self-management of urinary incontinence in women. This research has the potential to decrease the burden of one of the most prevalent and bothersome chronic conditions in women, as well as provide important new insights into physical and mental health factors that can influence bladder control and response to treatment.