Lessening Incontinence by Learning Yoga (LILY)
This study has been completed.
Sponsor:
University of California, San Francisco
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Urinary Incontinence Stress Urinary Incontinence Urge Urinary Incontinence Over Active Bladder |
Other: Yoga Therapy Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | August 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Yoga Therapy
Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
|
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
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alison Huang, Assistant Professor, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01672190 History of Changes |
| Other Study ID Numbers: | 12-09389 |
| Study First Received: | August 16, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Bladder, Overactive Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms Urinary Bladder Diseases |
ClinicalTrials.gov processed this record on May 22, 2013