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Completed

NCT Number: NCT01470560

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

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?

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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 names: MBSR developed by Jon Kabat-Zinn

Sham Yoga Group

Behavioral

Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body.

Primary outcomes

  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 outcomes

  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)).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: MBSR-Yoga

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 11, 2011
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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