Lessening Incontinence by Learning Yoga (LILY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alison Huang, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01672190
First received: August 16, 2012
Last updated: January 16, 2013
Last verified: January 2013

August 16, 2012
January 16, 2013
August 2012
December 2012   (final data collection date for primary outcome measure)
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01672190 on ClinicalTrials.gov Archive Site
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Lessening Incontinence by Learning Yoga
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Urinary Incontinence
  • Stress Urinary Incontinence
  • Urge Urinary Incontinence
  • Over Active Bladder
Other: Yoga Therapy Program
  • Experimental: Yoga Therapy
    Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
    Intervention: Other: Yoga Therapy Program
  • No Intervention: Control
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01672190
12-09389
No
Alison Huang, University of California, San Francisco
University of California, San Francisco
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Not Provided
University of California, San Francisco
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP