Clinical trial NCT01470560: Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
Official title: Mindfulness-Based Stress Reduction Techniques and Yoga for Treatment of Urinary Urge Incontinence (MBSR-Yoga)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Urinary Incontinence, Urge
Keywords: Mindfulness
Mindfulness-Based Stress Reduction
Meditation
Yoga
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-11-11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility 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)

Primary outcomes:
measure: Pre-Post Leakage Episodes
timeFrame: 0 (Baseline) and 8 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 0 (Baseline) and 8 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: