A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of a Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women

Conditions
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Stress Incontinence, Female, Stress Incontinence, Urinary, Stress Incontinence, Urge Incontinence, Urinary Incontinence, Stress, Urinary Stress Incontinence, Urgency Urinary

Intervention / Treatment
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* Other: Yoga Practice Program
* Other: Physical Conditioning Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Practice Program<br>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. | Other: Yoga Practice Program<br>* 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.<br>|
| Active Comparator: Physical Conditioning Program<br>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. | Other: Physical Conditioning Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Repeated change from baseline to 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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. | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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. | Repeated change from baseline to 6 and 12 weeks | 
| 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. | Repeated change from baseline to 6 and 12 weeks | 
| 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. | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks | 
| 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 | Repeated change from baseline to 6 and 12 weeks |