Lessening Incontinence by Learning Yoga

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility of recruiting women with urinary incontinence into a randomized controlled trial of a yoga therapy program.

Conditions
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Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Incontinence, Over Active Bladder

Intervention / Treatment
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* Other: Yoga Therapy Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 40 years or older who report urinary incontinence for > 3 months prior to screening Self-report at least 7 urinary incontinence episodes per week on a screening 7-day voiding diary Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the screening voiding diary Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study period Capable of understanding study procedures and giving informed consent Exclusion Criteria: Participation in a yoga class or other formal or organized yoga instruction in the past year Any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction Current use of medical therapy or device (i.e. pessary) for incontinence or use within the previous month Currently pregnant, gave birth within the past 6 months, or planning pregnancy during the study period Current urinary tract infection or a history or 3 or more urinary tract infections in the preceding year Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance Unable to get up from a supine to a standing position in 10 seconds or less and without assistance Severe obesity, defined as body mass index > 35 kg/m2 on screening examination Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months Report symptomatic pelvic organ prolapse Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study

Ages Eligible for Study
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Minimum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Therapy<br>Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks. | Other: Yoga Therapy Program<br> <br> |
| No Intervention: Control<br>Women in the Control Group will wait 6 weeks before receiving a gift certificate for yoga classes at an external yoga studio in the San Francisco Bay Area | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks |  | 6 weeks |