Lessening Incontinence by Learning Yoga (LILY)
Primary Purpose
Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Therapy Program
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility 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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yoga Therapy
Control
Arm Description
Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
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 Outcome Measures
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT01672190
First Posted
August 16, 2012
Last Updated
January 16, 2013
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01672190
Brief Title
Lessening Incontinence by Learning Yoga
Acronym
LILY
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Incontinence, Over Active Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Therapy
Arm Type
Experimental
Arm Description
Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Yoga Therapy Program
Primary Outcome Measure Information:
Title
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
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Lessening Incontinence by Learning Yoga
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