LILY: Lessening Incontinence by Learning Yoga

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01672190
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga Therapy Program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94115

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alison Huang, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01672190
Other Study ID Numbers:
  • 12-09389
First Posted:
Aug 24, 2012
Last Update Posted:
Jan 17, 2013
Last Verified:
Jan 1, 2013

Study Results

No Results Posted as of Jan 17, 2013