NCT01672190CompletedNot Applicable
Lessening Incontinence by Learning Yoga
University of California, San Francisco1 site in 1 country20 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Yoga Therapy
Experimental
Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
Intervention: Yoga Therapy Program (Other)
Control
No Intervention
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
Outcomes
Primary Outcomes
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Alison Huang
Assistant Professor
University of California, San Francisco
Study Sites (1)
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