LILA: Lessening Incontinence Through Low-impact Activity

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02342678
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Behavioral: Yoga Therapy; Behavioral: Physical Conditioning	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Lessening Incontinence Through Low-impact Activity, a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Yoga Therapy
Experimental: 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.	Behavioral: Physical Conditioning

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94115

Sponsors and Collaborators

• University of California, San Francisco
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Alison J Huang, MD, University of California, San Francisco

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 28, 2016

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02342678
• Other Study ID Numbers: 14-14732; 1R34AT008028-01A1
• First Posted: Jan 21, 2015
• Last Update Posted: Dec 19, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

Participant Flow

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	28	28
COMPLETED	27	23
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	28	28	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 57.1%	12 42.9%	28 50%
>=65 years	12 42.9%	16 57.1%	28 50%
Sex: Female, Male (Count of Participants)
Female	28 100%	28 100%	56 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Non-Latina White	18 64.3%	17 60.7%	35 62.5%
Latina White	1 3.6%	1 3.6%	2 3.6%
Asian/Asian-American	4 14.3%	6 21.4%	10 17.9%
Native Hawaiian or Pacific Islander	2 7.1%	2 7.1%	4 7.1%
Unknown	3 10.7%	2 7.1%	5 8.9%
Region of Enrollment (participants) [Number]
United States	28 100%	28 100%	56 100%
Incontinence Frequency (Episodes per day) [Mean (Standard Deviation) ]
Total Incontinence	3.8 (1.6)	3.1 (2.3)	3.5 (2.0)
Urgency Incontinence	2.1 (1.8)	2.3 (2.3)	2.2 (2.1)
Stress Incontinence	1.4 (1.5)	0.7 (1.1)	1.0 (1.4)
Urinary Symptom Questionnaire Scores (Scores on Scale) [Mean (Standard Deviation) ]
Incontinence Impact Questionnaire	117.9 (82.1)	133.9 (92.3)	125.9 (87.0)
Urogenital Distress Inventory-6	34.5 (16.4)	36.5 (19.5)	35.5 (17.8)
Patient Perception of Bladder Condition	3.4 (1.0)	3.3 (1.1)	3.4 (1.0)

Outcome Measures

1. Primary Outcome

Title	Total Incontinence Frequency
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [episodes per day]	-2.8	-1.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.3 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Stress-type Incontinence Frequency
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [Episodes per day]	-0.8	-0.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -0.2 to 1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Urgency-type Incontinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [Episodes per day]	-1.7	-1.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -1.2 to 1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Total Daytime Incontinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [Episodes per day]	-2.5	-1.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.3 to 2.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Total Nighttime Incontinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [Episodes per day]	-0.3	-0.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.3 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Incontinence Impact Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [scores on scale]	-74	-94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-19.3
	Confidence Interval	(2-Sided) 95%; -62.9 to 24.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Urogenital Distress Inventory-6
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [Scores on scale]	-21	-15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.6
	Confidence Interval	(2-Sided) 95%; -3.7 to 14.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Patient Perception of Bladder Condition
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Therapy Group	Physical Conditioning Group
Arm/Group Description	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	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
Measure Participants	28	28
Least Squares Mean (95% Confidence Interval) [scores on scale]	-1.3	-1.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Therapy Group, Physical Conditioning Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Yoga Therapy Group		Physical Conditioning Group
Arm/Group Description	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		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
All Cause Mortality
	Yoga Therapy Group		Physical Conditioning Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Serious Adverse Events
	Yoga Therapy Group		Physical Conditioning Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Yoga Therapy Group		Physical Conditioning Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/28 (60.7%)		14/28 (50%)
Ear and labyrinth disorders
Burst eardrum	0/28 (0%)	0	1/28 (3.6%)	1
Ear Infection	1/28 (3.6%)	1	0/28 (0%)	0
Eye disorders
Eye soreness/sensitivity	0/28 (0%)	0	1/28 (3.6%)	1
Macular Degeneration	0/28 (0%)	0	1/28 (3.6%)	1
Eye infection	0/28 (0%)	0	1/28 (3.6%)	1
Uveitis	1/28 (3.6%)	1	0/28 (0%)	0
Gastrointestinal disorders
Gastrointestinal Issues	0/28 (0%)	0	1/28 (3.6%)	1
Upcoming Endoscopy For Small Hernia	0/28 (0%)	0	1/28 (3.6%)	1
Musculoskeletal and connective tissue disorders
Broken Hand	1/28 (3.6%)	1	0/28 (0%)	0
Bursitis of left hip	1/28 (3.6%)	1	0/28 (0%)	0
Carpal Tunnel	0/28 (0%)	0	1/28 (3.6%)	1
Fall, Right arm	1/28 (3.6%)	1	0/28 (0%)	0
Foot sprain at site of old fracture	1/28 (3.6%)	1	0/28 (0%)	0
knee injury	0/28 (0%)	0	1/28 (3.6%)	1
Muscle or joint pain	1/28 (3.6%)	1	1/28 (3.6%)	1
Neck Injury	0/28 (0%)	0	1/28 (3.6%)	1
Pain in right leg/foot	0/28 (0%)	0	1/28 (3.6%)	1
Right knee stiffness	0/28 (0%)	0	1/28 (3.6%)	1
Sciatica	1/28 (3.6%)	1	0/28 (0%)	0
Severe right knee pain from previous injury	1/28 (3.6%)	1	0/28 (0%)	0
Thoracic pain	1/28 (3.6%)	1	0/28 (0%)	0
Toe Fracture	1/28 (3.6%)	1	0/28 (0%)	0
sprained ankle, hurt knee, and cracked patella	0/28 (0%)	0	1/28 (3.6%)	1
sprained wrist	0/28 (0%)	0	1/28 (3.6%)	1
Nervous system disorders
Headache	0/28 (0%)	0	1/28 (3.6%)	1
Migraine	1/28 (3.6%)	1	0/28 (0%)	0
Concussion	0/28 (0%)	0	1/28 (3.6%)	1
Transient Ischemic Attack	1/28 (3.6%)	1	0/28 (0%)	0
Psychiatric disorders
Depression	2/28 (7.1%)	2	0/28 (0%)	0
Mental Health Issues	0/28 (0%)	0	1/28 (3.6%)	1
Renal and urinary disorders
suspected prolapse	1/28 (3.6%)	1	0/28 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma Attack	0/28 (0%)	0	1/28 (3.6%)	1
Cold	4/28 (14.3%)	4	4/28 (14.3%)	4
Flu	3/28 (10.7%)	3	1/28 (3.6%)	1
Sinus Infection	0/28 (0%)	0	1/28 (3.6%)	1
Sinus Irritation	0/28 (0%)	0	1/28 (3.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.