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

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ClinicalTrials.gov Identifier: NCT01470560
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Jan Baker, University of Utah

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?


Condition or disease Intervention/treatment Phase
Urinary Incontinence Urinary Incontinence, Urge Behavioral: Mindfulness-Based Stress Reduction (MBSR) Behavioral: Sham Yoga Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
Study Start Date : February 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : February 2013

Arm Intervention/treatment
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.
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.

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.
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




Primary Outcome Measures :
  1. Pre-Post Leakage Episodes [ Time Frame: 0 (Baseline) and 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 0 (Baseline) and 8 weeks ]
    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)).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females at least 18 years of age
  2. 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.
  3. Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
  4. Request for treatment for urge urinary incontinence.
  5. Subject is able to complete all study related items and interviews.

Exclusion Criteria:

  1. Any current or recent (past 4 weeks) anticholinergic medication use. Patient may discontinue medication and after 4 weeks may be eligible for study.
  2. Past non-pharmacologic treatment for urge incontinence such as supervised behavioral therapy, supervised or unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
  3. Current symptomatic urinary tract infection that has not resolved prior start of MBSR group.
  4. 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?"
  5. Previous or currently implanted neuromodulation (sacral or tibial).
  6. Surgically altered detrusor muscle, such as augmentation cystoplasty.
  7. Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
  8. In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
  9. Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
  10. Currently pregnant or within 6 months postpartum (pregnancy is not excluded for safety reasons but for quality of data)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470560


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Additional Information:
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Responsible Party: Jan Baker, Advanced Practice Registered Nurse, University of Utah
ClinicalTrials.gov Identifier: NCT01470560    
Other Study ID Numbers: IRB00047159
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Keywords provided by Jan Baker, University of Utah:
Mindfulness
Mindfulness-Based Stress Reduction
Meditation
Yoga
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders