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Lessening Incontinence Through Low-impact Activity (LILA)

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ClinicalTrials.gov Identifier: NCT02342678
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The LILA study is a pilot randomized parallel-group trial of a group-based yoga therapy program versus physical conditionin control program for treatment of urinary incontinence in ambulatory middle-aged and older women. Women aged 50 years and older who meet the criteria for frequency of incontinence episodes, are not using other clinical treatments for incontinence, and meet minimum physical mobility requirements and other eligibility criteria will be recruited from the general San Francisco Bay Area.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Behavioral: Yoga Therapy Behavioral: Physical Conditioning Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lessening Incontinence Through Low-impact Activity, a.k.a. Yoga to Enhance Behavioral Self-Management of Urinary Incontinence in Women
Actual Study Start Date : January 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga Therapy Group
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Behavioral: Yoga Therapy
Experimental: Physical Conditioning Group
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Behavioral: Physical Conditioning



Primary Outcome Measures :
  1. Change in frequency of incontinence episodes. [ Time Frame: Baseline to 12-weeks ]

Secondary Outcome Measures :
  1. Change in baseline quality of life in women with UI [ Time Frame: Baseline to 12-weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 50 years or older who report urinary incontinence starting at least 3 months prior to screening
  • Self-report at least required frequency of urinary incontinence episodes on a screening 3-day voiding diary
  • Self-report urgency-predominant (i.e., at least half of incontinence episodes being urgency-type), stress-predominant (i.e., at least half of episodes being stress-type), or mixed-type (i.e., an equal number of stress- and urgency-type episodes) incontinence on the screening voiding diary
  • Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study intervention period

Exclusion Criteria:

  • Participation in formal or organized yoga classes or instruction within the past 3 months; or any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
  • Participation in at least weekly organized physical conditioning classes or instruction in the past 3 months involving muscle stretching and strengthening exercises (not including aerobic classes that do not emphasize stretching or strengthening).
  • Currently pregnant (by self-report or screening urine pregnancy test), gave birth within the past 6 months, or planning pregnancy during the study period (approximately 2 to 6 months)
  • Current urinary tract infection (screening dipstick urinalysis with leukocyte estrace, nitrites or blood) 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 (i.e., functional capacity < 4 METs)
  • Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
  • Morbid obesity defined by a measured body mass index of >40 kg/m2 at the screening evaluation.
  • 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 use of medications with the potential to affect incontinence (anticholinergic bladder medications, tricyclic antidepressants, selective norepinephrine reuptake inhibitors, mirabegron, loop diuretics) within the past month
  • Report starting stopping, or changing the dose of a medication with the potential to affect anxiety or stress symptoms (i.e., selective serotonin reuptake inhibitors, anxiolytics/sedatives, antipsychotics) within the past 1 month, or plans to start, stop, or change to dose of such a medication during the study period
  • Report use of medical devices (i.e. pessary) for incontinence within the previous month (participants may stop use of device and re-present for study)
  • Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
  • Report symptomatic pelvic organ prolapse (assessed using a standardized question, ""Have your pelvic organs (uterus, bladder, or rectum) been dropping out of your vagina causing a feeling of bulging, pressure, or protrusion or a sensation like your "insides are coming out"?")
  • 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
  • Unable to understand study procedures, complete study interviews, or and provide informed consent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342678


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Alison J Huang, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02342678     History of Changes
Other Study ID Numbers: 14-14732
1R34AT008028-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders