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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
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.
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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