Stress Incontinence, Stress Incontinence, Female, Stress Incontinence, Urinary, Urge Incontinence, Urgency Urinary, Urinary Incontinence, Stress, Urinary Stress Incontinence
Conditions
Brief summary
The investigators will conduct a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women and explore potential mediators of improvement in outcomes. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria will be recruited from multiple locations surrounding the San Francisco Bay area.
Interventions
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
The 3-month muscle stretching/strengthening intervention program (also referred to as the physical conditioning program) has been designed by the study physical therapist consultants.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women aged 45 years or older who report urinary incontinence starting at least 3 months prior to screening * Self-report an average of at least one incontinence episode per day on a validated 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
* Current participation in organized yoga classes or workshops, or any prior organized yoga training directed specifically at improving incontinence * Current participation in organized physical conditioning classes involving muscle strengthening exercises (e.g., Pilates) * Current urinary tract infection or hematuria detected by urinalysis at screening visit (women can re-present after evaluation and treatment through their usual care) * Currently pregnant (by self-report or screening urine pregnancy test), gave birth within the past 3 months, or planning pregnancy during the study period * Report use of medical devices (i.e. pessary) for incontinence within the past month (participants may stop use of device and re-present for study) * Report use of bladder botox, electrostimulation, formal bladder training, or formal pelvic floor exercise training (with certified practitioners) in the past 3 months * Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation * Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months * Unable to walk 2 blocks on level ground without assistance (functional capacity \< 4 metabolic equivalents) * Unable to get up from a supine to a standing position without assistance (assessed during the screening visit) * Report history of interstitial cystitis, bladder or rectal fistula, or congenital defect causing urinary incontinence * Report incontinence caused by a major neurologic conditions such as multiple sclerosis, spinal cord injury, or Parkinson's disease * Report use of medications with strong effects on urination (anticholinergic bladder medications, beta-3 agonists, tricyclic antidepressants, mirabegron, loop diuretics) within the past month * Report starting, stopping, or changing the dose of a medication with the potential to affect anxiety or depression 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 * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Urinary Incontinence Episodes | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urgency-Type Urinary Incontinence Episodes | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points |
| Change From Baseline in Incontinence Impact Questionnaire (IIQ) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-400, Higher score indicates lower quality of life |
| Change From Baseline in Urogenital Distress Inventory-6 Score (UDI) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-100, Higher score indicates lower quality of life |
| Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range 1-6, Higher score indicates lower quality of life |
| Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-60, Higher score indicates lower quality of life |
| Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 20-80, Higher score indicates lower quality of life |
| Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-21, Higher score indicates lower quality of life |
| Change From Baseline in Perceived Stress Scale (PSS) Score | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-40, Higher score indicates lower quality of life |
| Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points (Mean 50, Std Dev 10) no widely accepted thresholds have been published. Higher score indicates better quality of life |
| Change From Baseline in One-legged Balance Test (Winsorized) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life. |
| Change From Baseline in Chair Stands (in 30 Seconds) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life |
| Change From Baseline in 2-Minute Step Test | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life |
| Change From Baseline in Wake After Sleep Onset (Winsorized) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the follow-up value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life. |
| Change From Baseline in Stress-Type Urinary Incontinence Episodes | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points |
| Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range of 0-21, higher score indicates lower quality of life. |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized) | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life |
| Change From Baseline in Total Sleep Time | Repeated change from baseline to 6 and 12 weeks | Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Yoga Practice Program The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications.
Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. | 121 |
| Physical Conditioning Program The 3-month muscle stretching/strengthening intervention program (also referred to as the physical conditioning program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels.
Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the physical conditioning program) has been designed by the study physical therapist consultants. | 119 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Cannot tolerate intervention | 1 | 0 |
| Overall Study | COVID Related | 4 | 2 |
| Overall Study | Family | 2 | 2 |
| Overall Study | Incomplete outcome data | 6 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | No remote technology access | 0 | 1 |
| Overall Study | Serious Adverse Event | 0 | 1 |
| Overall Study | Too Busy | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Yoga Practice Program | Total | Physical Conditioning Program |
|---|---|---|---|
| 2-Minute Step Test | 85.9 steps STANDARD_DEVIATION 22.8 | 87.2 steps STANDARD_DEVIATION 24.5 | 88.5 steps STANDARD_DEVIATION 26.1 |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.7 | 62.1 years STANDARD_DEVIATION 8.7 | 61.4 years STANDARD_DEVIATION 8.8 |
| Center for Epidemiologic Studies Depression Scale (CES-D) | 10.1 units on a scale STANDARD_DEVIATION 8.8 | 10.0 units on a scale STANDARD_DEVIATION 8.4 | 10.0 units on a scale STANDARD_DEVIATION 8.1 |
| Chair Stands (in 30 seconds) | 12.6 chair stands STANDARD_DEVIATION 3.9 | 12.9 chair stands STANDARD_DEVIATION 4.1 | 13.1 chair stands STANDARD_DEVIATION 4.2 |
| Hospital Anxiety & Depression (HADS)--Anxiety score | 5.3 units on a scale STANDARD_DEVIATION 3.8 | 5.3 units on a scale STANDARD_DEVIATION 3.8 | 5.2 units on a scale STANDARD_DEVIATION 3.7 |
| Incontinence Impact Questionnaire (IIQ) | 100.4 units on a scale STANDARD_DEVIATION 78.9 | 101.0 units on a scale STANDARD_DEVIATION 72.7 | 101.6 units on a scale STANDARD_DEVIATION 66.4 |
| One-legged Balance Test | 24.4 seconds STANDARD_DEVIATION 9.9 | 24.9 seconds STANDARD_DEVIATION 9.4 | 25.5 seconds STANDARD_DEVIATION 8.7 |
| Patient Perception of Bladder Condition (PPBC) | 3.3 units on a scale STANDARD_DEVIATION 1 | 3.4 units on a scale STANDARD_DEVIATION 1 | 3.4 units on a scale STANDARD_DEVIATION 1 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active, Assessment of Arousal, Orgasm | 63.2 units on a scale STANDARD_DEVIATION 12.8 | 63.3 units on a scale STANDARD_DEVIATION 15.3 | 63.3 units on a scale STANDARD_DEVIATION 17.3 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active, Assessment of Desire | 48.6 units on a scale STANDARD_DEVIATION 18.1 | 49.4 units on a scale STANDARD_DEVIATION 18.2 | 50.1 units on a scale STANDARD_DEVIATION 18.3 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active, Condition-specifc Impacts on Activity | 86.2 units on a scale STANDARD_DEVIATION 13.9 | 86.6 units on a scale STANDARD_DEVIATION 13.3 | 87.0 units on a scale STANDARD_DEVIATION 12.8 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active, Condition-specific Impact on Sexual Quality | 81.4 units on a scale STANDARD_DEVIATION 23.4 | 80.4 units on a scale STANDARD_DEVIATION 21.8 | 79.4 units on a scale STANDARD_DEVIATION 20.3 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active, Global Quality | 62.2 units on a scale STANDARD_DEVIATION 28.3 | 63.2 units on a scale STANDARD_DEVIATION 28.1 | 64.0 units on a scale STANDARD_DEVIATION 28.1 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active Interest, Assessment of Partner Related Impacts | 77.2 units on a scale STANDARD_DEVIATION 17.1 | 77.1 units on a scale STANDARD_DEVIATION 18 | 77.0 units on a scale STANDARD_DEVIATION 19 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Active Interest, Summary Score | 68.8 units on a scale STANDARD_DEVIATION 13.2 | 68.9 units on a scale STANDARD_DEVIATION 13.5 | 68.9 units on a scale STANDARD_DEVIATION 13.8 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Inactive, Condition Impact on Sexual Quality | 21.6 units on a scale STANDARD_DEVIATION 26.9 | 17.8 units on a scale STANDARD_DEVIATION 24.7 | 13.6 units on a scale STANDARD_DEVIATION 21.6 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Inactive, Condition Specific Reason for Not Being Active | 24.8 units on a scale STANDARD_DEVIATION 21.9 | 22.4 units on a scale STANDARD_DEVIATION 22.1 | 19.6 units on a scale STANDARD_DEVIATION 22.2 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Inactive, Global Quality | 48.6 units on a scale STANDARD_DEVIATION 29.6 | 49.1 units on a scale STANDARD_DEVIATION 30.9 | 49.6 units on a scale STANDARD_DEVIATION 32.5 |
| Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR) PISQ-IR Sexually Inactive, Partner-Related Reasons for Not Being Active | 56.8 units on a scale STANDARD_DEVIATION 26 | 58.3 units on a scale STANDARD_DEVIATION 24.8 | 60.0 units on a scale STANDARD_DEVIATION 23.6 |
| Perceived Stress Scale (PSS) score | 13.0 units on a scale STANDARD_DEVIATION 7.2 | 13.2 units on a scale STANDARD_DEVIATION 7 | 13.3 units on a scale STANDARD_DEVIATION 6.8 |
| Pittsburgh Sleep Quality Index (PSQI) total score | 6.2 units on a scale STANDARD_DEVIATION 3.1 | 6.4 units on a scale STANDARD_DEVIATION 3.1 | 6.6 units on a scale STANDARD_DEVIATION 3.1 |
| PROMIS Physical 8B, T-Score | 51.0 T-Score STANDARD_DEVIATION 6.2 | 51.2 T-Score STANDARD_DEVIATION 6.5 | 51.3 T-Score STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized American Indian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 20 Participants | 40 Participants | 20 Participants |
| Race/Ethnicity, Customized Black | 7 Participants | 19 Participants | 12 Participants |
| Race/Ethnicity, Customized Hispanic | 21 Participants | 32 Participants | 11 Participants |
| Race/Ethnicity, Customized More than one race | 11 Participants | 20 Participants | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 83 Participants | 160 Participants | 77 Participants |
| Region of Enrollment United States | 121 Participants | 240 Participants | 119 Participants |
| Sex: Female, Male Female | 121 Participants | 240 Participants | 119 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| State/Trait Anxiety Inventory (STAI)--Trait | 36.1 units on a scale STANDARD_DEVIATION 11.2 | 36.1 units on a scale STANDARD_DEVIATION 10.9 | 36.1 units on a scale STANDARD_DEVIATION 10.5 |
| Stress-Type Urinary Incontinence Episodes | 1.4 episodes per day STANDARD_DEVIATION 1.8 | 1.4 episodes per day STANDARD_DEVIATION 1.6 | 1.4 episodes per day STANDARD_DEVIATION 1.5 |
| Total sleep time | 7.1 Hours STANDARD_DEVIATION 1.2 | 7.0 Hours STANDARD_DEVIATION 1.1 | 7.0 Hours STANDARD_DEVIATION 1 |
| Total Urinary Incontinence Episodes | 3.6 episodes per day STANDARD_DEVIATION 2.5 | 3.4 episodes per day STANDARD_DEVIATION 2.2 | 3.2 episodes per day STANDARD_DEVIATION 1.9 |
| Urgency-Type Urinary Incontinence Episodes | 2.1 episodes per day STANDARD_DEVIATION 2.2 | 1.9 episodes per day STANDARD_DEVIATION 1.9 | 1.7 episodes per day STANDARD_DEVIATION 1.4 |
| Urogenital distress inventory-6 score (UDI) | 39.1 units on a scale STANDARD_DEVIATION 19.1 | 38.8 units on a scale STANDARD_DEVIATION 19.2 | 38.5 units on a scale STANDARD_DEVIATION 19.4 |
| Wake after sleep onset | 24.4 minutes STANDARD_DEVIATION 29.2 | 24.8 minutes STANDARD_DEVIATION 27.4 | 25.2 minutes STANDARD_DEVIATION 25.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 119 |
| other Total, other adverse events | 37 / 121 | 43 / 119 |
| serious Total, serious adverse events | 1 / 121 | 1 / 119 |
Outcome results
Primary
Change From Baseline in Total Urinary Incontinence Episodes
Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points.
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Total Urinary Incontinence Episodes | -1.99 episodes per day |
| Physical Conditioning Program | Change From Baseline in Total Urinary Incontinence Episodes | -1.7 episodes per day |
Comparison: Null Hypothesis: Yoga is not associated with improvement in change from baseline in Total Urinary Incontinence Episodesp-value: 0.05695% CI: [-0.01, 0.6]Mixed Models Analysis
Secondary
Change From Baseline in 2-Minute Step Test
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in 2-Minute Step Test | 8.05 steps |
| Physical Conditioning Program | Change From Baseline in 2-Minute Step Test | 9.03 steps |
p-value: 0.68995% CI: [-3.87, 5.84]Mixed Models Analysis
Secondary
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-60, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | -0.82 units on a scale |
| Physical Conditioning Program | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | -0.52 units on a scale |
p-value: 0.76495% CI: [-1.69, 2.3]Mixed Models Analysis
Secondary
Change From Baseline in Chair Stands (in 30 Seconds)
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Chair Stands (in 30 Seconds) | 1 chair stands |
| Physical Conditioning Program | Change From Baseline in Chair Stands (in 30 Seconds) | 1.98 chair stands |
p-value: 0.04395% CI: [0.03, 1.93]Mixed Models Analysis
Secondary
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-21, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score | -0.21 units on a scale |
| Physical Conditioning Program | Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score | -0.33 units on a scale |
p-value: 0.75395% CI: [-0.83, 0.6]Mixed Models Analysis
Secondary
Change From Baseline in Incontinence Impact Questionnaire (IIQ)
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-400, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Incontinence Impact Questionnaire (IIQ) | -31.3 units on a scale |
| Physical Conditioning Program | Change From Baseline in Incontinence Impact Questionnaire (IIQ) | -30.4 units on a scale |
p-value: 0.91195% CI: [-13.6, 15.23]Mixed Models Analysis
Secondary
Change From Baseline in One-legged Balance Test (Winsorized)
Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life.
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in One-legged Balance Test (Winsorized) | 1.34 seconds |
| Physical Conditioning Program | Change From Baseline in One-legged Balance Test (Winsorized) | 1.53 seconds |
p-value: 0.74395% CI: [-0.95, 1.34]Mixed Models Analysis
Secondary
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range 1-6, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | -0.59 units on a scale |
| Physical Conditioning Program | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | -0.52 units on a scale |
p-value: 0.56495% CI: [-0.16, 0.3]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm | 0.83 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm | -1.55 units on a scale |
p-value: 0.15495% CI: [-5.68, 0.91]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire | 0.08 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire | -1.3 units on a scale |
p-value: 0.49595% CI: [-5.36, 2.61]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity | 3.7 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity | 1.95 units on a scale |
p-value: 0.28795% CI: [-5, 1.5]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality | 2.84 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality | 0.62 units on a scale |
p-value: 0.37595% CI: [-7.17, 2.72]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality | 2.75 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality | -0.07 units on a scale |
p-value: 0.30395% CI: [-8.22, 2.59]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)
Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized) | -2.52 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized) | 0.45 units on a scale |
p-value: 0.19695% CI: [-1.56, 7.51]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score
Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domain is relevant only the sexually active participants
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score | 1.47 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score | -0.16 units on a scale |
p-value: 0.14795% CI: [-3.85, 0.58]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality | -5.04 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality | -3.83 units on a scale |
p-value: 0.74795% CI: [-6.25, 8.67]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active
Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active | -1 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active | -3.76 units on a scale |
p-value: 0.45995% CI: [-10.2, 4.65]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality | 1.3 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality | -0.67 units on a scale |
p-value: 0.55695% CI: [-10.2, 4.65]Mixed Models Analysis
Secondary
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active | 1.73 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active | -1.52 units on a scale |
p-value: 0.51695% CI: [-13.2, 6.7]Mixed Models Analysis
Secondary
Change From Baseline in Perceived Stress Scale (PSS) Score
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-40, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Perceived Stress Scale (PSS) Score | -0.44 units on a scale |
| Physical Conditioning Program | Change From Baseline in Perceived Stress Scale (PSS) Score | -0.72 units on a scale |
p-value: 0.68595% CI: [-1.63, 1.07]Mixed Models Analysis
Secondary
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range of 0-21, higher score indicates lower quality of life.
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score | -0.37 units on a scale |
| Physical Conditioning Program | Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score | -0.66 units on a scale |
p-value: 0.31995% CI: [-0.86, 0.28]Mixed Models Analysis
Secondary
Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points (Mean 50, Std Dev 10) no widely accepted thresholds have been published. Higher score indicates better quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score | -0.2 T-score |
| Physical Conditioning Program | Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score | 0.04 T-score |
p-value: 0.69195% CI: [-0.95, 1.43]Mixed Models Analysis
Secondary
Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 20-80, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait | -1.22 units on a scale |
| Physical Conditioning Program | Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait | -1.34 units on a scale |
p-value: 0.88395% CI: [-1.78, 1.53]Mixed Models Analysis
Secondary
Change From Baseline in Stress-Type Urinary Incontinence Episodes
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Stress-Type Urinary Incontinence Episodes | -0.8 episodes per day |
| Physical Conditioning Program | Change From Baseline in Stress-Type Urinary Incontinence Episodes | -0.77 episodes per day |
p-value: 0.75795% CI: [-0.15, 0.2]Mixed Models Analysis
Secondary
Change From Baseline in Total Sleep Time
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life.
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Total Sleep Time | 0 hours |
| Physical Conditioning Program | Change From Baseline in Total Sleep Time | 0.09 hours |
p-value: 0.44895% CI: [-0.15, 0.34]Mixed Models Analysis
Secondary
Change From Baseline in Urgency-Type Urinary Incontinence Episodes
Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Urgency-Type Urinary Incontinence Episodes | -1.12 episodes per day |
| Physical Conditioning Program | Change From Baseline in Urgency-Type Urinary Incontinence Episodes | -0.9 episodes per day |
p-value: 0.04895% CI: [0, 0.45]Mixed Models Analysis
Secondary
Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-100, Higher score indicates lower quality of life
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Urogenital Distress Inventory-6 Score (UDI) | -14.9 units on a scale |
| Physical Conditioning Program | Change From Baseline in Urogenital Distress Inventory-6 Score (UDI) | -11.7 units on a scale |
p-value: 0.04195% CI: [0.13, 6.13]Mixed Models Analysis
Secondary
Change From Baseline in Wake After Sleep Onset (Winsorized)
Change was calculated as the follow-up value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life.
Time frame: Repeated change from baseline to 6 and 12 weeks
Population: Number of participants with outcomes data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Yoga Practice Program | Change From Baseline in Wake After Sleep Onset (Winsorized) | -3.55 minutes |
| Physical Conditioning Program | Change From Baseline in Wake After Sleep Onset (Winsorized) | -6.96 minutes |
p-value: 0.27695% CI: [-9.54, 2.74]Mixed Models Analysis