Lessening Incontinence by Learning Yoga

NCT ID: NCT01672190

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence; Urge Urinary Incontinence; Over Active Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yoga Therapy

Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.

Group Type: EXPERIMENTAL

Yoga Therapy Program

Intervention Type: OTHER

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Yoga Therapy Program

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Alison Huang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

12-09389

Identifier Type: -

Identifier Source: org_study_id