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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672190

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
  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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on August 28, 2014