Lessening Incontinence by Learning Yoga

NCT01672190 | Completed

• 1 other identifier: 12-09389
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Study Arms (2)

Yoga Therapy

EXPERIMENTAL

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

Other: Yoga Therapy Program

Control

NO INTERVENTION

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

Interventions

Yoga Therapy Program OTHER

Yoga Therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)