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

Urinary Incontinence Clinical Trial

— MBSR-Yoga  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470560
• Other study ID #: IRB00047159
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: December 10, 2014
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Post Leakage Episodes	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.	0 (Baseline) and 8 weeks	No
Secondary	Quality of Life	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)).	0 (Baseline) and 8 weeks	No

External Links

•   Mindfulness Based Stress Reduction Program Description