- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672190
Lessening Incontinence by Learning Yoga (LILY)
January 16, 2013 updated by: Alison Huang, University of California, San Francisco
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94115
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Yoga Therapy
Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 16, 2012
First Submitted That Met QC Criteria
August 21, 2012
First Posted (Estimate)
August 24, 2012
Study Record Updates
Last Update Posted (Estimate)
January 17, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-09389
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
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University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
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Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
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Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
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San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
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Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
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Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark
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ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
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Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
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University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
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NYU Langone HealthRecruiting
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University of California, San FranciscoStanford University; National Center for Complementary and Integrative Health...CompletedPelvic Pain | Chronic Pelvic Pain | Recurrent Pelvic PainUnited States
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Institut du Cancer de Montpellier - Val d'AurelleCompleted
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States