Abstract
Background:
Pelvic floor yoga has been recommended as a complementary treatment strategy for urinary incontinence (UI) in women, but evidence of its efficacy is lacking.
Objective:
To evaluate the effects of a therapeutic pelvic floor yoga program versus non-specific physical conditioning program on UI in women.
Design:
Randomized trial
Setting:
Three study sites in California, United States
Participants:
Ambulatory women aged 45 or older reporting daily urgency-, stress-, or mixed-type UI
Interventions:
12-week program of twice-weekly group instruction and once weekly self-directed practice of pelvic floor-specific Hatha yoga techniques (pelvic yoga), versus equivalent-time instruction and practice of general skeletal muscle stretching and strengthening exercises (physical conditioning)
Measurements:
Total and type-specific UI frequency assessed by 3-day voiding diaries
Results:
Among the 240 randomized (age range 45–90 years), mean (SD) baseline UI frequency was 3.4 (2.2) episodes/day, including 1.9 (1.9) urgency-type and 1.4 (1.7) stress-type episodes/day. Over 12 weeks, total UI frequency (primary outcome) decreased by an average of 2.3 episodes/day with pelvic yoga and 1.9 episodes/day with physical conditioning (between-group difference of −0.3 episodes/day [95%CI −0.7, 0.0]). Urgency-type UI frequency decreased by 1.2 episodes/day in the pelvic yoga and 1.0 episodes/day in the physical conditioning group (between-group difference of −0.3 episodes/day [95%CI −0.5, 0.0]). Reductions in stress-type UI frequency did not differ between groups (−0.1 episodes/day [95%CI −0.3, 0.3]).
Limitations:
No comparison to no treatment or other clinical UI treatments; conversion to videoconference-based intervention instruction during the COVID-19 pandemic.
Conclusions:
A 12-week pelvic yoga program was not superior to a general muscle stretching and strengthening program in reducing clinically important UI in midlife and older women with daily UI.
Funding:
National Institutes of Health
Registration:
Introduction
One in three midlife and older women experience urinary incontinence (UI), a condition leading to depression, social isolation, physical inactivity, functional decline, and institutionalization (1–5). Nearly half of affected women report receiving no treatment, however, in part due to difficulty getting access to effective and well-tolerated UI therapies (6, 7). First-line behavioral management strategies such as pelvic floor exercises and bladder retraining can be difficult for women to practice effectively without ongoing support from healthcare practitioners (8–11). Second-line pharmacologic treatments have side effects leading to frequent discontinuation, while third-line therapies involve costly procedures with clinical subspecialists (12–14). Consequently, many women are interested in alternate treatment strategies that are not only effective but more accessible and better tolerated (15–17).
One complementary modality already used by many women with UI is pelvic floor yoga (18, 19). When practiced in a way that emphasizes mindful awareness of bodily structures, yoga can increase awareness and engagement of the pelvic floor muscles. Regular practice of physical yoga postures can also improve general skeletal muscle conditioning (20, 21) as a potentially modifiable risk factor for UI in older or deconditioned women (22–26). Yogic breathing and relaxation techniques have also been reported to improve resting autonomic function or stress-related autonomic reactivity (27–30), implicated in bladder detrusor muscle overactivity (31–34). As a potential community-based UI self-management strategy, yoga can also be practiced without continuous supervision by clinical specialists.
However, the efficacy for yoga for UI and other pelvic floor conditions has not been evaluated in rigorous trials (35–37). Studies of yoga for other aging-associated syndromes have not detected benefits above other physical-based activities, suggesting that hypothesized benefits may not be unique to yoga (38). Women may also be concerned that practice of yoga could worsen their UI by increasing pressure on the bladder or precipitating urges to urinate.
Methods
Design Overview
This study is a randomized, investigator-blinded, superiority trial to evaluate the efficacy and safety of a group-based pelvic yoga intervention versus non-specific skeletal muscle stretching-strengthening intervention for improving UI frequency and associated quality of life in ambulatory midlife and older women (protocol included as a Supplement).
Setting and Participants
Participants were women aged 45 years and older recruited from the communities surrounding 3 northern California sites by personnel at the University of California San Francisco or Stanford University. Participants were eligible if they reported predominantly urgency-, stress-, or mixed-type UI for at least 3 months; documented at least daily UI on a 3-day voiding diary; and met mobility criteria such as being able to walk two blocks on level ground. Also excluded were candidates already engaged in organized yoga or muscle conditioning activities, using pharmacologic UI treatments in the past month, or using formal behavioral or invasive UI treatments in the past 3 months.
Other exclusionary criteria included prior anti-incontinence or other bladder or urethral surgery; other pelvic surgery in the past 3 months; current or recent pregnancy; 3 or more urinary tract infections (UTIs) in the past year; UI resulting from major neurologic conditions; bladder or rectal fistula; congenital urinary tract defect; symptomatic pelvic organ prolapse; interstitial cystitis; or evidence of UTI on screening urinalysis performed by study personnel. Participants taking diuretic, antidepressant, anxiolytic, or antipsychotic medications had to be on stable doses for 1 month.
Randomization and Interventions
Participants were randomized in a fixed 1:1 ratio to a 12-week program of study-specific pelvic floor yoga techniques (pelvic yoga) or a time-equivalent non-specific skeletal muscle stretching and strengthening exercises (physical conditioning). Randomization was performed by computer in permuted blocks of 2 and 4, stratified by predominant UI type and clinical site, using an allocation sequence prepared by an independent statistician and concealed from study personnel. Participants and study staff responsible for monitoring adherence were aware of intervention assignment, but investigators and staff ascertaining outcomes were blinded.
To minimize differential expectations of benefit, participants were told that the study involved two types of low-impact, physical interventions, with neither yet known to be effective for UI. Intervention credibility was assessed by asking participants to rate how “logical” they considered their newly assigned intervention and how “successful” they expected it to be in improving UI, from 0 (worst) to 9 (best) (39).
The pelvic yoga program focused on yoga techniques selected by a panel of expert yoga consultants for their potential to improve pelvic floor function and feasibility for women across the aging spectrum. The program focused on a core set of 16 standard Hatha yoga postures, including active postures engaging the pelvic floor and more passive postures promoting relaxation (Supplemental Table 1). Informed by Iyengar yoga, a form of Hatha yoga employed in studies of yoga for other health indications (40–47), the program emphasized attention to postural alignment, use of yoga props to minimize risk of injury, and mindful awareness during practice of postures.
Each yoga class series was led by an instructor with at least 2 years of experience teaching yoga, who completed study-specific training and engaged in twice monthly quality assurance meetings with study consultants. Class series began with a 90-minute group orientation to the principles of alignment-based yoga; use of yoga props; and anatomy of the pelvis, spine, and lower extremity. Participants subsequently attended 90-minute group classes twice weekly for 12 weeks with an average of 6 students. Instructors followed a study manual describing a standard order for introducing postures, adaptation of postures to promote pelvic floor awareness, and use of props to accommodate limitations with strength or flexibility. Outside of class, participants were asked to practice at least one additional hour per week and maintain a practice log. Participants were given a written manual including descriptions and pictures of postures, along with a yoga mat, belt, bolster, and blocks.
The physical conditioning program was designed to provide a rigorous time-and-attention control for the pelvic yoga program, given the potential for bias in participant-reported outcomes arising from differential expectations of treatment benefit. The program also featured twice weekly 90-minute group classes for 12 weeks led by personal trainers or physical therapists trained and supervised by the study’s physical therapy consultant. Classes focused on non-specific upper and lower extremity stretching and strengthening exercises to improve skeletal muscle conditioning but avoid engaging the pelvic floor or promoting mindful relaxation (Supplemental Table 2). Similar to yoga participants, physical conditioning participants were instructed to practice outside of class at least an hour per week and maintain a practice log. Each received a written practice manual, exercise mat, stretch strap, and resistance bands.
Prior to March 2020, intervention classes were conducted in person in brick-and-mortar yoga or exercise studios in northern California. After COVID-19 shelter-in-place orders were issued, instruction was converted to an institution-supported videoconference platform, although classes continued to involve live, synchronous group instruction. Participants were subsequently required to have videoconference-enabled computers or tablets and broadband internet access, although study staff provided tablet tripods.
Participants in both groups received a written pamphlet providing patient-directed information about first-line behavioral self-management strategies for UI (48). However, participants received no additional instruction in practicing these techniques during the trial.
Outcomes and Follow-up
Frequency and type of UI were assessed at baseline, 6 weeks, and 12 weeks using a validated 3-day voiding diary (49, 50), in which participants recorded each time they leaked urine and classified leakage episodes by clinical type. Participants completing the 12-week intervention programs were also asked to complete and return diaries after 24 and 36 weeks for assessment of persistent changes in UI. Diary data were abstracted by blinded analysts.
Additional structured questionnaire measures assessed urinary symptom-related bother and interference at the same timepoints: the Urogenital Distress Inventory-6 (UDI-6), measuring subjective distress from symptoms including urgency- and stress-type UI (score range 0–100) (51); the Incontinence Impact Questionnaire (IIQ), assessing the impact of UI on physical activity, emotional health, relationships, and travel (score range 0–400) (52); and the Patient Perception of Bladder Condition (PPBC), a single-item measure of the degree to which respondents considered their bladder symptoms to be a problem (score range 0–6) (53).
To monitor safety, study personnel systematically queried participants about any negative changes in health at each follow-up contact. Reported events were recorded as adverse events.
Statistical analysis
Sample size calculations assumed an average baseline total UI frequency of 3.5 episodes/day, standard deviation of change in UI frequency of 3.6 episodes/day, and up to a 50% decrease in UI frequency in the physical conditioning group. A total sample size of 220 was originally selected to provide 80% power with 2-sided type-1 error of 5% to detect a 20% greater reduction in the primary outcome of total UI frequency (0.7 fewer episodes/day) with pelvic yoga over 12 weeks. In 2021, mean baseline UI frequency was observed to be lower than anticipated, and total sample size was changed to 250 to improve statistical power and then to 240 based on updated parameter estimates.
Linear mixed models (LMMs) were developed to examine repeated changes in UI outcomes 6 and 12 weeks after initiation of treatment, adjusting for baseline levels of outcomes, study site, as well as predominant baseline UI type. LMMs were run using Proc Mixed with fixed effects for visit, baseline UI type, site and baseline outcome value, and nested subject within class random effects, using variance components covariance structure (see Appendix for statistical code). Estimates of UI change were derived using least square means.
The original analysis plan included a time-by-treatment interaction for comparison of the effect of pelvic yoga versus physical conditioning on the primary efficacy outcome of change in total UI frequency from baseline to 12 weeks. Secondary efficacy outcome analyses examined between-group differences in 12-week changes in urgency-type, stress-type, daytime, and night-time UI frequency, as well as urinary symptom questionnaire. All original analyses were conducted according to intervention assignment, without regard to adherence, using all available outcomes data. Approximate normality of the residuals was verified using by inspection of Q-Q plots, and change values were 99% winsorized when plots indicated skewed distributions.
Subsequent testing did not detect evidence of significant difference in intervention effects by time (changes from baseline to 6 versus 12 weeks) (based on the arm-by-visit interaction for change in total, stress, and urge UI, respectively). Consequently, additional post hoc treatment effect analyses were based on LMMs without a time-by-treatment interaction for the repeated changes in UI frequency from baseline assessed over both 6 and 12 weeks, assuming approximately constant treatment effects over time (Appendix).
Additional protocol-proposed analyses were performed to examine and address missing data through attrition or nonresponse. Baseline characteristics of participants who did and did not contribute 12-week data were compared. Multiple imputation (MI) analyses were also performed on all randomized participants (54). Twenty multiply imputed datasets were created using the Markov chain Monte Carlo method. Imputation models included demographic characteristics, treatment assignment, and repeated measures outcomes at each timepoint. Three sets of MI models were developed—one for type-specific UI frequency (with all UI types in the same model, and total UI estimates calculated as the sum of all type-specific UI estimates), one for daytime and nighttime UI frequency, and one for urinary symptom questionnaire scores. Summary effect estimates and standard errors were computed by standard methods for imputed data.
Additional exploratory models examined persistent post-intervention changes in outcomes over 24 and 36 weeks. Further protocol-specified analyses assessed for interaction between intervention effects and baseline participant age, race, ethnicity, predominant UI type, and physical function, based on a two-sided P value of 0.05.
Participants’ ratings of intervention credibility and expectations of treatment success were examined at baseline. Retention and adherence to interventions were examined in each intervention arm. Safety analyses examined adverse events detected in each arm. All analyses were performed with SAS statistical software (version 9.4; SAS Institute Inc, Cary, NC).
Role of the Funding Source
The study was funded by the National Institutes of Health, which had no role in the design of the study; collection, analysis, or interpretation of the data; or decision to approve or publish the manuscript.
Results
Recruitment and Retention
Between December 2018 and September 2022, 121 participants were randomized to pelvic yoga and 119 to physical conditioning (Figure). Seventy-six (31.7%) were randomized in intervention waves involving all in-person instruction, and 164 (68.3%) in waves involving primarily videoconference instruction. Three participants randomized immediately before COVID-19 shelter-in-place orders in March 2020 dropped out before receiving any intervention instruction. Fifteen assigned to pelvic yoga (12.4%) and 11 to physical conditioning (9.2%) discontinued interventions before 12 weeks. Twenty-four participants in the pelvic yoga and 24 in the physical conditioning group were additionally lost to follow-up during the extended post-intervention follow-up period from 12 to 36 weeks. The trial ended in December 2022 when the last participant completed 36-week post-intervention follow-up.
Figure 1: CONSORT (Consolidated Standards of Reporting Trials) Flow Diagram.
During the exploratory 24- and 36-week post-intervention follow-up period, follow-up data were missing for an additional 24 participants in the pelvic yoga group (including 20 lost to follow-up, 1 with an adverse event, 1 who was too busy, and 2 for other reasons), and for another 24 participants in the physical conditioning group (including 21 lost to follow-up, 2 with adverse events, and 1 for other reasons).
The mean (SD) participant age was 62.0 (8.7) years (range of 45 to 90 years). Thirteen percent of participants self-identified as Hispanic or Latina, 7.9% Black, 20.1% Asian, and 8.3% multiracial (Table 1). Approximately 60% reported having UI for at least 5 years. 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 episodes/day.
Table 1.
Baseline Characteristics of Randomized Participants, by Intervention Assignment
| Pelvic yoga (n=121) | Physical conditioning (n=119) | |
|---|---|---|
|
| ||
| Age (in years) | ||
| Mean (SD) age | 62.7 (8.7) | 61.4 (8.8) |
| Total age range | 45 to 90 | 46 to 80 |
|
| ||
| Race | ||
| Asian | 20 (16.5%) | 20 (16.8%) |
| Black or African American | 7 (5.8%) | 12 (10.1%) |
| Multiple race | 11 (9.1%) | 9 (7.6%) |
| Other or unknown | 0 (0.0%) | 1 (0.8%) |
| White or Caucasian | 83 (68.6%) | 77 (64.7%) |
|
| ||
| Ethnicity | ||
| Hispanic or Latina | 21 (17.4%) | 11 (9.2%) |
|
| ||
| Education | ||
| High school or less | 5 (4.1%) | 5 (4.2%) |
| Some college but no college degree | 18 (14.9%) | 13 (10.9%) |
| College degree or more | 98 (81.0%) | 101 (84.9%) |
|
| ||
| Gynecologic history | ||
| Parity (total live births) | 1.6 (1.2) | 1.5 (1.1) |
| Nulliparous | 35 (28.9%) | 28 (23.5%) |
| History of oophorectomy | 9 (7.4%) | 12 (10.1%) |
| History of hysterectomy | 17 (14.0%) | 22 (18.5%) |
| Postmenopausal | 106 (87.6%) | 95 (79.8%) |
|
| ||
| Self-reported health conditions | ||
| Arthritis | 40 (33.1%) | 32 (26.9%) |
| Obstructive lung disease | 21 (17.4%) | 19 (16.0%) |
| Diabetes mellitus | 8 (6.6%) | 9 (7.6%) |
| Heart disease | 6 (5.0%) | 2 (1.7%) |
|
| ||
| Health-related habits | ||
| Current cigarette smoking | 0 (0.0%) | 1 (0.8%) |
| Former cigarette smoking | 29 (24.0%) | 25 (21.0%) |
| Current weekly alcohol use | 57 (47.1%) | 52 (43.7%) |
| Physical activity per week (METs/week) | 2,270.3 (2353.6) | 1,896.0 (1738.5) |
|
| ||
| Body mass index (in kg/m2)* | ||
| Mean (SD) | 27.4 (5.1) | 27.1 (5.7) |
|
| ||
| Predominant incontinence type | ||
| Urgency or urgency predominant | 74 (61.2%) | 72 (60.5%) |
| Stress or stress predominant | 47 (38.8%) | 47 (39.5%) |
|
| ||
| Incontinence frequency (episodes/day) | ||
| Any incontinence frequency | 3.6 (2.5) | 3.2 (1.9) |
| Urgency incontinence frequency | 2.1 (2.2) | 1.7 (1.4) |
| Stress incontinence frequency | 1.4 (1.8) | 1.4 (1.5) |
| Other incontinence frequency | 0.1 (0.5) | 0.1 (0.4) |
|
| ||
| Duration of incontinence | ||
| 5 or more years ago | 72 (59.5%) | 73 (61.3%) |
| At least 1 but less than 5 years ago | 44 (36.4%) | 40 (33.6%) |
| Less than 1 year ago | 5 (4.1%) | 6 (5.0%) |
|
| ||
| Urinary symptom questionnaire scores * | ||
| Incontinence Impact Questionnaire (IIQ) | 100.4 (78.9) | 101.6 (66.4) |
| Urogenital Distress Inventory (UDI-6) | 39.1 (19.1) | 38.5 (19.4) |
| Patient Perception of Bladder Condition (PPBC) | 3.3 (1.0) | 3.4 (1.0) |
Data are presented as mean (standard deviation) or number (percent).
Data are missing for 1 participant for body mass index and 3 participants for urinary symptom questionnaire scores.
At baseline, participants in both groups considered their assigned interventions to be similarly logical (7.6 [1.5] on a 0–9 scale for pelvic yoga and 7.3 [1.7] for physical conditioning group) and likely to be similarly successful in improving UI (6.9 [1.6] on a 0–9 scale for pelvic yoga and 6.7 [1.7] for physical conditioning). Among participants completing 12-week interventions, 84.9% assigned to pelvic yoga and 89.1% to physical conditioning attended at least 80% of intervention classes, although participant self-confidence in practicing intervention techniques was lower in the pelvic yoga versus physical conditioning group (Supplemental Table 3).
UI frequency outcomes
Thirty participants were missing 12-week UI frequency data (Supplemental Table 4; Supplemental Figures 1, 2, and 3). In these participants, average BMI was higher, diabetes prevalence was higher, and stress UI frequency was lower, compared to participants with 12-week data (Supplemental Table 5).
In original protocol-proposed models estimating change from baseline to 12 weeks, the estimated between-group difference in change in total UI frequency with pelvic yoga versus physical conditioning was −0.3 episodes/day [95%CI −0.7, 0.0]; P=0.054) (Table 2). The estimated between-group difference in change in urgency-type UI frequency was −0.3 episodes/day (95%CI −0.5, 0.0). Changes in stress-type UI frequency from baseline to 12 weeks were similar in both groups (between-group difference of −0.1 episodes/day [95%CI −0.3, 0.2]).
Table 2.
Change in Urinary Incontinence Frequency and Urinary Symptom Questionnaire Scores from Baseline to 12 Weeks of Intervention, Based on Original Protocol-Specified Analyses
| Urinary incontinence frequency outcomes | Pelvic yoga (N=106) | Physical conditioning (N=113) | Between-group difference |
|---|---|---|---|
| Mean change (95%CI)* | Mean change (95%CI)* | Mean change (95%CI)* | |
| Total urinary incontinence episodes per day (primary trial outcome/endpoint) | −2.3 (−2.5, −2.0) | −1.9 (−2.2, −1.7) | −0.3 (−0.7, 0.0) |
| Urgency-type incontinence episodes per day | −1.2 (−1.4, −1.0) | −1.0 (−1.2, −0.8) | −0.3 (−0.5, 0.0) |
| Stress-type incontinence episodes per day | −1.0 (−1.1, −0.8) | −0.9 (−1.1, −0.8) | −0.1 (−0.3, 0.2) |
| Nighttime incontinence episodes per night† | −0.2 (−0.3, −0.2) | −0.2 (−0.2, −0.1) | −0.1 (−0.1, 0.0) |
| Daytime incontinence episodes per day | −2.0 (−2.3, −1.8) | −1.8 (−2.0, −1.6) | −0.2 (−0.6, 0.1) |
| Urinary symptom questionnaire outcomes | Pelvic yoga (N=108) | Physical conditioning (N=112) | Between-group difference |
| Mean change (95%CI)* | Mean change (95%CI)* | Mean change (95%CI)* | |
| Urogenital Distress Inventory-6 (UDI-6) | −18.5 (−21.1, −15.8) | −13.5 (−16.2, −10.9) | −4.9 (−8.6, −1.2) |
| Incontinence Impact Questionnaire (IIQ)‡ | −38.5 (−49.6, −27.4) | −32.0 (−43.1, −21.0) | −6.4 (−22.0, 9.1) |
| Patient perception of bladder condition (PPBC)‡ | −0.7 (−0.9, − 0.5) | −0.7 (−0.9, −0.5) | −0.0 (−0.3, 0.3) |
Estimates of mean change values and 95% confidence intervals are derived from linear mixed models including both 6- and 12-week timepoints with a time-by-treatment interaction term, adjusted for baseline values as well as study site and predominant clinical incontinence type. Models include participants with follow-up data for each outcome at either 6 or 12 weeks; values are least square mean estimates and confidence intervals for change at 12 weeks.
Based on winsorized data on nighttime urinary incontinence frequency.
For the IIQ and PPBC measures, only 107 participants in the pelvic yoga group were analyzed, due to missing data for 1 participant at both 6 and 12 weeks.
Similar intervention effects were observed in post-hoc models examining average changes from baseline to both 6 and 12 weeks and omitting the time-by-treatment interaction (Table 3). In additional analyses imputing missing data over 6 and 12 weeks, however, estimates of between-group differences in change in UI frequency were further attenuated (Table 4).
Table 3.
Change in Urinary Incontinence Frequency and Urinary Symptom Questionnaire Scores, from Post Hoc Analyses Combining Change from Baseline to Both 6 and 12 Weeks of Intervention
| Urinary incontinence frequency outcomes | Pelvic yoga (N=106) | Physical conditioning (N=113) | Between-group difference |
|---|---|---|---|
| Mean change (95%CI)* | Mean change (95%CI)* | Mean change (95%CI)* | |
| Total urinary incontinence episodes per day | −2.0 (−2.2, −1.8) | −1.7 (−1.9, −1.5) | −0.3 (−0.6, 0.0) |
| Urgency-type incontinence episodes per day | −1.1 (−1.3, −1.0) | −0.9 (−1.1, −0.7) | −0.2 (−0.5, 0.0) |
| Stress-type incontinence episodes per day | −0.8 (−0.9, −0.7) | −0.8 (−0.9, −0.7) | −0.0 (−0.2, 0.2) |
| Nighttime incontinence episodes per night† | −0.2 (−0.3, −0.2) | −0.2 (−0.2, −0.1) | −0.0 (−0.1, 0.0) |
| Daytime incontinence episodes per day | −1.8 (−2.0, −1.6) | −1.6 (−1.8, −1.4) | −0.2 (−0.5, 0.1) |
| Urinary symptom questionnaire outcomes | Pelvic yoga (N=108) | Physical conditioning (N=112) | Between-group difference |
| Mean change (95%CI)* | Mean change (95%CI)* | Mean change (95%CI)* | |
| Urogenital Distress Inventory-6 (UDI-6) | −14.9 (−17.0, −12.7) | −11.7 (−13.9, −9.6) | −3.1 (−6.1, −0.1) |
| Incontinence Impact Questionnaire (IIQ)‡ | −31.3 (−41.6, −20.9) | -30.4 (−40.7, −20.2) | -0.8 (−15.2, 13.6) |
| Patient perception of bladder condition (PPBC)‡ | −0.6 (−0.8, −0.4) | −0.5 (−0.7, −0.4) | −0.1 (−0.3, 0.2) |
Estimates of mean change values and 95% confidence intervals are derived from linear mixed models including both 6- and 12-week timepoints, without a time-by-treatment interaction term, adjusted for baseline values as well as study site and predominant clinical incontinence type. Models include participants with follow-up data for each outcome at either 6 or 12 weeks; values are least square mean estimates of change at both follow-up timepoints.
Based on winsorized data on nighttime urinary incontinence frequency.
For the IIQ and PPBC measures, only 107 participants in the pelvic yoga group were analyzed, due to missing data for 1 participant at both 6 and 12 weeks.
Table 4.
Change in Urinary Incontinence Frequency and Urinary Symptom Questionnaire Scores from Baseline to 6 and 12 Weeks of Intervention, with Imputation of Missing Data*
| Urinary incontinence frequency outcomes | Pelvic yoga (N=121) | Physical conditioning (N=119) | Between-group difference |
|---|---|---|---|
| Mean change (95%CI) | Mean change (95%CI) | Mean change (95%CI) | |
| Total urinary incontinence episodes per day | −2.0 (−2.2, −1.7) | −1.7 (−1.9, −1.5) | −0.2 (−0.6, 0.1) |
| Urgency-type incontinence episodes per day | −1.2 (−1.3, −1.0) | −1.0 (−1.1, −0.8) | −0.2 (−0.4, 0.0) |
| Stress-type incontinence episodes per day | −0.7 (−0.9, −0.6) | −0.7 (−0.8, −0.6) | −0.0 (−0.2, 0.2) |
| Nighttime incontinence episodes per night† | −0.2 (−0.2, −0.2) | −0.2 (−0.2, −0.1) | −0.0 (−0.1, 0.0) |
| Daytime incontinence episodes per day | −1.7 (−2.0, −1.5) | −1.6 (1.8, −1.3) | −0.2 (−0.5, 0.1) |
| Urinary symptom questionnaire outcomes | Pelvic yoga (N=121) | Physical conditioning (N=119) | Between-group difference |
| Mean change (95%CI) | Mean change (95%CI) | Mean change (95%CI) | |
| Urogenital Distress Inventory-6 (UDI-6) | −14.8 (−17.1, −12.6) | −11.9 (−14.1, −9.8) | −2.9 (−5.9, 0.1) |
| Incontinence Impact Questionnaire (IIQ) | −31.3 (−41.3, −21.2) | −31.1 (−41.2, −21.0) | −0.2 (−14.3, 13.9) |
| Patient perception of bladder condition (PPBC) | −0.6 (−0.8, −0.4) | −0.5 (−0.7, −0.4) | −0.0 (−0.3, 0.2) |
Least square mean estimates of change and 95% confidence intervals are derived from linear mixed models, including both 6- and 12-week timepoints, adjusted for baseline values as well as study site and predominant urinary incontinence type. Twenty multiply imputed datasets were created using the Markov chain Monte Carlo method, which included demographic characteristics, treatment assignment, and repeated measures outcomes at each timepoint; separate models were developed for type-specific UI frequency and for urinary symptom questionnaire scores; summary effect estimates and standard errors were computed by standard methods for imputed data.
Based on winsorized data on nighttime urinary incontinence frequency.
Urinary symptom bother and interference
In original protocol-specified models examining change from baseline to 12 weeks (Table 2), pelvic yoga was associated with an average 4.9-point greater decrease in UDI-6 scores [95%CI −8.6, −0.1]. No significant between-group differences were detected in change in overall IIQ scores or PPBC scores. Similar effects were observed in post-hoc models examining least square means change from baseline to both 6 and 12 weeks (Table 3). In supplementary models imputing missing data for urinary questionnaire scores over 6 and 12 weeks (Table 4), the estimated between-group difference in change in UDI-6 score was diminished (−2.8 [95%CI −5.9, 0.1]).
Subgroup analyses
Protocol-specified interaction testing did not detect significant differences in intervention effects on UI frequency, bother, or interference outcomes based on age, Black race or Latina ethnicity, predominant clinical UI type, or baseline PROMIS physical function score. Additional post-hoc testing did not detect differences in intervention effects by mode of instruction (predominantly in-person versus videoconference).
Persistent post-intervention outcomes
At 24 weeks, 72 of 91 (79.1%) participants returning from the pelvic yoga and 72 of 99 (72.7%) returning from the physical conditioning group reported continuing to engage in self-directed intervention practice. At 36 weeks, 57 of 83 (68.7%) returning in the pelvic yoga and 54 of 86 (62.8%) in the physical conditioning group reported continued self-directed practice.
In models imputing missing data over 24 and 36 weeks (Supplemental Table 6), change in total UI frequency associated with pelvic yoga versus physical conditioning was −0.2 episodes/day (95%CI −0.6, 0.1). Urgency-type UI frequency decreased by 0.3 more episodes/day with pelvic yoga than physical conditioning (95%CI −0.6, −0.0). No significant between-group differences in change in other UI frequency or urinary symptom questionnaire scores over 24 and 36 weeks were detected (Supplemental Tables 6 and 7).
Safety outcomes
During the 12-week intervention period, 45 adverse events were reported in the pelvic yoga and 47 in the physical conditioning group (Table 5). Only one serious adverse event was detected (atrial fibrillation hospitalization) before 12 weeks, which occurred in the physical conditioning group but was considered unrelated to study participation.
Table 5.
Adverse Events Reported Over 12 Weeks, by Intervention Assignment and Medical Dictionary for Regulatory Activities (MedDRA) Organ System Class
| Pelvic yoga (N=121) | Physical conditioning (N =119) | |
|---|---|---|
| Number of adverse events | 45 | 47 |
| Number of participants with an adverse event | 26 | 35 |
| Number of participants with a serious adverse event | 0 | 1 |
| Number of deaths | 0 | 0 |
| Cardiac disorders | 1 | 1 |
| Ear disorders | 0 | 1 |
| Eye disorders | 0 | 1 |
| Gastrointestinal disorders | 4 | 5 |
| General disorders ad administration site disorders | 0 | 1 |
| Immune disorders | 2 | 1 |
| Infections and infestations | 7 | 3 |
| Injury, poisoning and procedural complications | 1 | 5 |
| Investigations | 1 | 1 |
| Musculoskeletal and connective tissue disorders | 16 | 18 |
| Nervous system disorders | 2 | 3 |
| Psychiatric disorders | 1 | 0 |
| Respiratory, thoracic and mediastinal Disorders | 2 | 1 |
| Skin and subcutaneous tissue Disorders | 1 | 1 |
| Surgical and medical procedures | 1 | 0 |
| Vascular disorders | 1 | 0 |
Discussion
Although pelvic yoga has been recommended for women with pelvic floor conditions such as urinary incontinence, rigorous evidence of the efficacy of yoga for this indication is lacking. In this randomized trial in midlife and older women with daily UI, a pelvic yoga intervention was not superior to an equivalent-time general muscle stretching and strengthening exercise program in reducing clinically important UI.
These findings are notable in light of other recent research on yoga as a therapeutic strategy for a variety of aging-associated syndromes. Compared with inactive or educational controls, yoga interventions have been reported to improve gait speed, extremity strength, and other aspects of a physical performance; however, there is little evidence that yoga improves aging outcomes or frailty markers over other active exercise interventions (38). In the current trial, participants also reported less confidence in their ability to practice yoga intervention techniques after 12 weeks compared to physical conditioning exercises, suggesting greater challenges engaging with yoga versus non-specific exercise.
Limited previous studies have explored yoga among individuals with pelvic health conditions, with several non-randomized studies reporting decreases in UI with various styles of yoga (35–37). The few randomized trials of yoga for UI have all had small sample sizes, however, including pilot studies that were not designed to evaluate efficacy (55–58). While the current study does not indicate a clinically important benefit of yoga over other physical interventions for treatment of UI, it does provide evidence to assuage concerns that the practice of yoga could worsen UI, given that women in the pelvic yoga group reported a more than 60% average decrease in all-type and urgency-type UI frequency over 12 weeks. Nevertheless, approaches to yoga also vary widely in the community, and our findings may not extrapolate to all forms of yoga.
Strengths of this research include enrollment of participants across diverse ages and ethnic backgrounds and careful procedures to promote equipoise in administration and evaluation of interventions. However, limitations include the inability to blind participants, although interventions appeared similarly credible. Assessment of the primary outcome was based on participant self-report, although the instrument used (voiding diary) is less susceptible to bias than other self-report measures (59). Loss-to-follow-up and missing data during the 12-week interventions could have introduced bias into assessment of treatment effects, and participant follow-up was also lower during the exploratory 24- and 36-week post-intervention periods.
Because all participants were assigned to an active intervention, findings cannot be used to determine the efficacy of yoga compared to no intervention at all. Observed improvements in UI in the yoga group could have resulted from natural reversion of symptoms over time, although over 95% of participants had UI for at least a year, and 60% for at least 5 years. Participants may also have benefitted from receiving written information about behavioral self-management of UI, although they received no reinforcement in practicing behavioral management.
In post hoc analyses, pelvic yoga was associated with modestly greater improvements in urgency-type UI over both 6 and 12 weeks, compared to physical conditioning. In contrast to stress-type UI, urgency-type UI is more common in older women, more likely to overlap with other geriatric syndromes, and more strongly associated with depression and anxiety (61, 62). As a pleiotropic behavioral intervention, yoga may offer greater therapeutic benefit for urgency UI as an inherently more complex syndrome. However, changes in type-specific UI were secondary outcomes only and require more investigation.
Finally, this study reflects the impact of the COVID-19 pandemic on behavioral intervention research, as shelter-in-place orders necessitated a dramatic shift in intervention delivery. Although interaction testing did not indicate treatment differences based on mode of intervention instruction, the efficacy of yoga may differ when delivered by videoconference rather than in-person. Conversion to videoconference-based instruction may also have decreased the representativeness of the study, as candidates without access to videoconference tools could not participate.
Nevertheless, findings provide rigorous data to evaluate the unique efficacy of yoga as a complementary treatment modality for UI. Despite perceived improvements in UI among women assigned to yoga, this intervention did not result in greater clinically meaningful improvement in UI compared to equivalent-time non-specific muscle conditioning exercise. Future research should investigate potential effects of yoga on type-specific UI and factors underlying perceived improvements in UI among older women engaged in yoga and other physical interventions.
Supplementary Material
Acknowledgments
The LILA trial was supported by National Institute of Diabetes Digestive and Kidney Disorders grant R01AG050588 and National Institutes of Health Office of Research on Women’s Health supplemental award R01DK116712–04S1, and A.J.H. was additionally supported by National Institute on Aging grant K24AG068601. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
A.J.H. has served as a paid technical advisor to the Rand Corporation for research on urinary incontinence unrelated to this report. No other potential conflicts of interest are reported by the authors.
The authors gratefully acknowledge the contributions of LILA clinical trial team members who played an important role in participant recruitment and data collection: Ann Chang (project manager), Lisa Abinanti (project manager), Traci Plaut (clinical research coordinator), Sarah Chatfield (clinical research coordinator), Amy Du (clinical research coordinator), Kathryn Batham (clinical research coordinator), Natalie Petersen (clinical research coordinator), and Ekhlas Abdulraheem (clinical research coordinator).
The authors also wish to express their gratitude to multiple other individuals who contributed to trial intervention refinement and delivery, including: Leslie Howard, E-RYT 500 (yoga consultant), Judith Lasater, PhD, PT (yoga consultant), Susan McCormick, CIYT (yoga instructor), Katherine Lindeburg (yoga instructor), Emily Combs, ERYT 500 (yoga instructor), Stephanie Sandleben (yoga instructor), Liane Yukl (yoga instructor), Jeanna Lurie,E-RYT 500, RPYT (yoga instructor), Gina Guaiumi (physical conditioning instructor), Carolyn Rae Gondek (physical conditioning instructor), Brent Kobs, PT, DPT (physical conditioning instructor), Giana Lando, CSCS (physical conditioning instructor), Robin Schroeder, PT, DPT (physical conditioning instructor), Kolten Lundholm (exercise physiologist, physical conditioning instructor), and Erin Rahter, PT, DPT (physical conditioning instructor).
Funding:
The research presented in this manuscript was supported by National Institutes of Health grants R01AG050588, R01DK116712–04S1, and K24AG068601.
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