Lessening Incontinence by Learning Yoga

Urinary Incontinence Clinical Trial

— LILY  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672190
• Other study ID #: 12-09389
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: January 16, 2013
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Over Active Bladder
• Stress Urinary Incontinence
• Urge Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Intervention

Other:
• Yoga Therapy Program

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks		6 weeks	No