Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Jan Baker, University of Utah

ClinicalTrials.gov Identifier:

NCT01470560

First received: November 9, 2011

Last updated: May 14, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 9, 2011
Last Updated Date	May 14, 2012
Start Date ^ICMJE	February 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 9, 2011)	Pre-Post Leakage Episodes [ Time Frame: 0 (Baseline) and 8 weeks ] [ Designated as safety issue: No ] The primary outcome for the study is the change from baseline in mean number of urge incontinent episodes from pre treatment to post-treatment measured using 3-day voiding diaries.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01470560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 9, 2011)	Quality of Life [ Time Frame: 0 (Baseline) and 8 weeks ] [ Designated as safety issue: No ] Secondary Outcome Measures are a change from baseline in the Overactive Bladder Questionnaire (OABq-SF) scores and proportion of subjects reporting improvement from the Patient Global Impression of Improvement (PGI-I)).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
Official Title ^ICMJE	Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
Brief Summary	Many women experience the accidental loss of urine called urge incontinence or overactive bladder (OAB) incontinence. Women describe this as a sudden, strong desire to pass urine which results in leakage before reaching the toilet. The current usual treatments for urge incontinence include behavioral treatment, physical therapy, and medicines. Although these treatments have been found to be effective in research studies, they are less effective over time in general practice. Because medicines have side effects, many women stop them. The purpose of this study is to explore different treatments that may provide another option for women with urge incontinence that might be effective. This is an initial study to see if these treatments are at least as effective as the usual treatments. Hypothesis: Does Mind Based Stress Reduction(MBSR)(meditation practices)reduce urinary urge incontinence episodes?
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Urinary Incontinence Urinary Incontinence, Urge
Intervention ^ICMJE	Behavioral: Mindfulness-Based Stress Reduction (MBSR) Mindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions. Other Name: MBSR developed by Jon Kabat-Zinn Behavioral: Sham Yoga Group Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body.
Study Arm (s)	Sham Comparator: Sham Yoga Group Treatment Sham yoga group (control group) will attend 8 weekly sessions for 1-2 hours and will be lead by a certified yoga instructor. The yoga class will be based on Pantajali's Eight Fold Path which is the basis of Yoga. Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body. Intervention: Behavioral: Sham Yoga Group Active Comparator: MBSR Group Treatment Mindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions. Intervention: Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Completion Date	Not Provided
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Females at least 18 years of age Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type. Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary. Request for treatment for urge urinary incontinence. Subject is able to complete all study related items and interviews. Exclusion Criteria: Any current or recent (past 4 weeks) anticholinergic medication use. Patient may discontinue medication and after 4 weeks may be eligible for study. Past non-pharmacologic treatment for urge incontinence such as supervised behavioral therapy, supervised or unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation. Current symptomatic urinary tract infection that has not resolved prior start of MBSR group. Symptoms of pelvic organ prolapse screened by PFDI (Pelvic Floor Disorder Inventory question #3) "Do you have a bulge or something falling out that you can see or feel in the vaginal area?" Previous or currently implanted neuromodulation (sacral or tibial). Surgically altered detrusor muscle, such as augmentation cystoplasty. Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease). In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary. Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome. Currently pregnant or within 6 months postpartum (pregnancy is not excluded for safety reasons but for quality of data)
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01470560
Other Study ID Numbers ^ICMJE	IRB00047159
Has Data Monitoring Committee	No
Responsible Party	Jan Baker, University of Utah
Study Sponsor ^ICMJE	University of Utah
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Utah
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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