Urinary Incontinence
Conditions
Brief summary
The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy program versus physical conditionin control program for treatment of urinary incontinence in ambulatory middle-aged and older women. Women aged 50 years and older who meet the criteria for frequency of incontinence episodes, are not using other clinical treatments for incontinence, and meet minimum physical mobility requirements and other eligibility criteria will be recruited from the general San Francisco Bay Area.
Interventions
BEHAVIORALYoga Therapy
BEHAVIORALPhysical Conditioning
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women aged 50 years or older who report urinary incontinence starting at least 3 months prior to screening * Self-report at least required frequency of urinary incontinence episodes on a screening 3-day voiding diary * Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary * Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period
Exclusion criteria
* Participation in formal or organized yoga classes or instruction within the past 3 months; or any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction * Participation in at least weekly organized physical conditioning classes or instruction in the past 3 months involving muscle stretching and strengthening exercises (not including aerobic classes that do not emphasize stretching or strengthening). * Currently pregnant (by self-report or screening urine pregnancy test), gave birth within the past 6 months, or planning pregnancy during the study period (approximately 2 to 6 months) * Current urinary tract infection (screening dipstick urinalysis with leukocyte estrace, nitrites or blood) or a history or 3 or more urinary tract infections in the preceding year * Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms * Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance (i.e., functional capacity \< 4 METs) * Unable to get up from a supine to a standing position in 10 seconds or less and without assistance * Morbid obesity defined by a measured body mass index of \>40 kg/m2 at the screening evaluation. * Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason * Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months * Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months * Report use of medications with the potential to affect incontinence (anticholinergic bladder medications, tricyclic antidepressants, selective norepinephrine reuptake inhibitors, mirabegron, loop diuretics) within the past month * Report starting stopping, or changing the dose of a medication with the potential to affect anxiety or stress symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period * Report use of medical devices (i.e. pessary) for incontinence within the previous month (participants may stop use of device and re-present for study) * Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage * Report symptomatic pelvic organ prolapse (assessed using a standardized question, Have your pelvic organs (uterus, bladder, or rectum) been dropping out of your vagina causing a feeling of bulging, pressure, or protrusion or a sensation like your insides are coming out?) * Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises * Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia * Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study * Unable to understand study procedures, complete study interviews, or and provide informed consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Incontinence Frequency | Baseline and 3 months | Change in the frequency of urinary incontinence episodes of any type. Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urgency-type Incontinence | Baseline and 3 months | Change in frequency of urgency-type incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
| Total Daytime Incontinence | Baseline to 3 months | Change in frequency of total daytime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
| Total Nighttime Incontinence | Baseline to 3 months | Change in frequency of total nighttime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
| Stress-type Incontinence Frequency | Baseline and 3 Months | Change in the frequency of stress-type incontinence episodes Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
| Urogenital Distress Inventory-6 | Baseline to 3 months | Change in the questionnaire score for Urogenital Distress Inventory-6. Range 0-100, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
| Patient Perception of Bladder Condition | Baseline to 3 months | Change in questionnaire score for Patient Perception of Bladder Condition. Range 1-6, with higher score mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
| Incontinence Impact Questionnaire | Baseline to 3 months | Change in questionnaire score for Incontinence Impact Questionnaire. Range 0-400, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Yoga Therapy Group Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy | 28 |
| Physical Conditioning Group Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Family illness/emergency | 0 | 1 |
| Overall Study | Illness/medical reason | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Too busy to complete study | 0 | 2 |
Baseline characteristics
| Characteristic | Yoga Therapy Group | Physical Conditioning Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 16 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 12 Participants | 28 Participants |
| Incontinence Frequency Stress Incontinence | 1.4 Episodes per day STANDARD_DEVIATION 1.5 | 0.7 Episodes per day STANDARD_DEVIATION 1.1 | 1.0 Episodes per day STANDARD_DEVIATION 1.4 |
| Incontinence Frequency Total Incontinence | 3.8 Episodes per day STANDARD_DEVIATION 1.6 | 3.1 Episodes per day STANDARD_DEVIATION 2.3 | 3.5 Episodes per day STANDARD_DEVIATION 2 |
| Incontinence Frequency Urgency Incontinence | 2.1 Episodes per day STANDARD_DEVIATION 1.8 | 2.3 Episodes per day STANDARD_DEVIATION 2.3 | 2.2 Episodes per day STANDARD_DEVIATION 2.1 |
| Race/Ethnicity, Customized Asian/Asian-American | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Latina White | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Non-Latina White | 18 Participants | 17 Participants | 35 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Urinary Symptom Questionnaire Scores Incontinence Impact Questionnaire | 117.9 Scores on Scale STANDARD_DEVIATION 82.1 | 133.9 Scores on Scale STANDARD_DEVIATION 92.3 | 125.9 Scores on Scale STANDARD_DEVIATION 87 |
| Urinary Symptom Questionnaire Scores Patient Perception of Bladder Condition | 3.4 Scores on Scale STANDARD_DEVIATION 1 | 3.3 Scores on Scale STANDARD_DEVIATION 1.1 | 3.4 Scores on Scale STANDARD_DEVIATION 1 |
| Urinary Symptom Questionnaire Scores Urogenital Distress Inventory-6 | 34.5 Scores on Scale STANDARD_DEVIATION 16.4 | 36.5 Scores on Scale STANDARD_DEVIATION 19.5 | 35.5 Scores on Scale STANDARD_DEVIATION 17.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 17 / 28 | 14 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Total Incontinence Frequency
Change in the frequency of urinary incontinence episodes of any type. Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline and 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Total Incontinence Frequency | -2.8 episodes per day |
| Physical Conditioning Group | Total Incontinence Frequency | -1.9 episodes per day |
p-value: 0.1395% CI: [-0.3, 2.2]ANCOVA
Secondary
Incontinence Impact Questionnaire
Change in questionnaire score for Incontinence Impact Questionnaire. Range 0-400, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline to 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Incontinence Impact Questionnaire | -74 scores on scale |
| Physical Conditioning Group | Incontinence Impact Questionnaire | -94 scores on scale |
p-value: 0.3895% CI: [-62.9, 24.3]ANCOVA
Secondary
Patient Perception of Bladder Condition
Change in questionnaire score for Patient Perception of Bladder Condition. Range 1-6, with higher score mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline to 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Patient Perception of Bladder Condition | -1.3 scores on scale |
| Physical Conditioning Group | Patient Perception of Bladder Condition | -1.0 scores on scale |
p-value: 0.4695% CI: [-0.4, 0.9]ANCOVA
Secondary
Stress-type Incontinence Frequency
Change in the frequency of stress-type incontinence episodes Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline and 3 Months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Stress-type Incontinence Frequency | -0.8 Episodes per day |
| Physical Conditioning Group | Stress-type Incontinence Frequency | -0.4 Episodes per day |
p-value: 0.1895% CI: [-0.2, 1.1]ANCOVA
Secondary
Total Daytime Incontinence
Change in frequency of total daytime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline to 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Total Daytime Incontinence | -2.5 Episodes per day |
| Physical Conditioning Group | Total Daytime Incontinence | -1.6 Episodes per day |
p-value: 0.1395% CI: [-0.3, 2]ANCOVA
Secondary
Total Nighttime Incontinence
Change in frequency of total nighttime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline to 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Total Nighttime Incontinence | -0.3 Episodes per day |
| Physical Conditioning Group | Total Nighttime Incontinence | -0.2 Episodes per day |
p-value: 0.7395% CI: [-0.3, 0.4]ANCOVA
Secondary
Urgency-type Incontinence
Change in frequency of urgency-type incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline and 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Urgency-type Incontinence | -1.7 Episodes per day |
| Physical Conditioning Group | Urgency-type Incontinence | -1.7 Episodes per day |
p-value: 0.8995% CI: [-1.2, 1.3]ANCOVA
Secondary
Urogenital Distress Inventory-6
Change in the questionnaire score for Urogenital Distress Inventory-6. Range 0-100, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Time frame: Baseline to 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Therapy Group | Urogenital Distress Inventory-6 | -21 Scores on scale |
| Physical Conditioning Group | Urogenital Distress Inventory-6 | -15 Scores on scale |
p-value: 0.2495% CI: [-3.7, 14.8]ANCOVA