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

Not Applicable

Completed

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

Interventions: Other: Yoga Practice Program
Other: Physical Conditioning Program

Registration Number: NCT03672461

Lead Sponsor: University of California, San Francisco

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 240

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga Practice Program	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.
Physical Conditioning Program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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 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 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 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 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 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 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, 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 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 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 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.
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 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 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

Trial Locations

Locations (2): Stanford University
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Palo Alto, California, United States
University of California, San Francisco
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San Francisco, California, United States