Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.

Detailed Description
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The overarching goal of this research is to evaluate potential treatment options for older women with symptoms of urinary urge incontinence, with a specific focus on Mindfulness-Based Stress Reduction, a promising therapeutic approach in preliminary studies and one increasingly used to treat symptoms associated with brain-visceral interactions. Feasibility and preliminary efficacy will be tested in two randomized study arms: a Mindfulness-Based Stress Reduction intervention group and a Health Enhancement Program intervention comparison group. This research study will explore the feasibility and preliminary efficacy of treating urinary urge incontinence in older adult women with mindfulness-based stress reduction in comparison to the health enhancement program through a randomized controlled pilot study. Feasibility determinants will include both research feasibility (recruitment, retention, treatment fidelity) and intervention feasibility (acceptability, tolerability, treatment adherence). Clinical outcomes to evaluate preliminary intervention efficacy will include severity of urinary urge incontinence symptoms, bother of urinary urge incontinence symptoms, perceived stress, and perceived level of self-efficacy of self-management of urinary urge incontinence symptoms. Preliminary efficacy of the intervention will also be evaluated with the Patient Global Impression of Improvement, a process measure that rates the patient's response of a condition to a therapy (Ryan, n.d., p. 1). This combined pilot feasibility study and randomized controlled trial will evaluate specific factors crucial to the success of a large trial to evaluate the effect of Mindfulness-Based Stress Reduction on urinary urge incontinence in older adult women. Moore (2011) recommended that the pilot study design parallel the future larger study, particularly when evaluating feasibility in the pilot study. The capacity for hypothesis testing, or establishing causal inference is limited in a pilot study due to insufficient power; however, the information from efficacy testing is vital in informing future larger scale clinical trials. This study will serve as a necessary step for the development of effectiveness trials of Mindfulness-Based Stress Reduction in treatment of urinary urge incontinence in older adult women by informing and guiding evaluation, implementation, and dissemination.

Official Title
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Comparing Mindfulness-Based Stress Reduction With the Health Enhancement Program in the Treatment of Urinary Urge Incontinence in Older Adult Women: A Pilot Feasibility and Randomized Controlled Trial

Conditions
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Urinary Incontinence, Urge, Urinary Incontinence in Old Age

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Health Enhancement Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following eligibility criteria must be met for the potential participant to be considered for enrollment. The study is enrolling older adult women, with urinary urge incontinence. They cannot be currently treating their urinary urge incontinence with medication as this will confound results. Women who have attempted more extreme treatments and are still experiencing urinary urge incontinence will not be considered as potential participants, as it is unlikely that mindfulness-based stress reduction would treat urinary urge incontinence that is refractory to that degree. Participants must be English speaking, as the interventions and homework will be delivered in English. postmenopausal women Urge predominant urinary incontinence, defined as score of ≥ 3 (moderate to severe urinary incontinence) on the Incontinence Severity Index Urge predominant urinary incontinence as determined by question 3 on the 3 Incontinence Questions. The 3 Incontinence Questions has been shown to be a quick and accurate way of diagnosing stress, urge or mixed incontinence in most cases Has experienced urinary urge incontinence symptoms for at least three months Committed to attend 8 weekly sessions and one half day retreat between weeks 6 and 7 No pharmacologic therapy for urinary urge incontinence within three weeks of enrollment and no plan to initiate such medications during the 8 week active treatment If on hormone therapy or vaginal estrogen, plan to remain on it for the duration of the study; if not on it, no plan to initiate No previous intradetrusor Botox injection for urinary urge incontinence and no plan to receive it during the intervention No previous neurostimulation for urinary urge incontinence and no plan to receive it during the intervention English speaking A score of >24 on the Montreal Cognitive Assessment Exclusion Criteria: The following exclusions are applied, as they could seriously limit participation or confound participant response to the intervention: Predominantly stress, mixed, or other type of incontinence as determined by question 3 on the 3 Incontinence Questions Currently taking medications for Alzheimer's disease or other dementias; these medications could interfere with their participation Known neurologic disease acknowledged to impact bladder function including Parkinson's disease, spinal cord injury, or stroke affecting urinary control; these diseases provide cause for urinary urge incontinence and as such the participant would be unlikely to benefit from the intervention Current symptomatic urinary tract infection that has not resolved prior to the start of intervention Current bladder infection that has not resolved prior to the start of intervention Use of an assistive device for ambulation (such as a cane, walker, or wheelchair) and feels that difficulties with bladder management are related to the slowed time in visiting the restroom (Was urinary urge incontinence a problem before you began using the assistive device?) Functionally incontinent, in other words, having a mental or physical condition that prevents a person from visiting the restroom in time Ever diagnosed with interstitial cystitis Self-report of vaginal bulge protruding outside of the vagina Past participation in a formal program of mindfulness-based stress reduction Substantial, uncorrected hearing loss Substantial, uncorrected vision loss Limitations that preclude completing study questionnaires or surveys, such as difficulties with reading and writing or a cognitive impairment

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two armed study with intervention and comparison groups running parallel to one another
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor | Behavioral: Mindfulness-Based Stress Reduction<br>* This experimental arm presents the actual Mindfulness-Based Stress Reduction program as developed in the late seventies and early eighties in its original eight week format<br>|
| Active Comparator: Health Enhancement Program<br>8 week manualized, standardized health enhancement program, taught by a certified health education specialist | Behavioral: Health Enhancement Program<br>* This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of potential participants contacted | number of people who contacted PI during recruitment process, including the place they heard about the study | 10 weeks | 
| number of enrolled participants completing the study | number of participants who attended at least five of nine classes number of excused absences number of unexcused absences | 12 weeks | 
| percentage of course content delivered during intervention | weekly interventionist report on what was taught participants perception of course content delivered measured by a checklist of concepts covered in the weekly interventions at study completion | 44 weeks | 
| positive or negative coded responses to the question How did it go today? | data coded from two participants' responses after each class in each arm | 8 weeks | 
| number of participants who completed each week's homework practice | participants mark on homework practice log and submit weekly | 8 weeks | 
| number of participants recruited for enrollment | potential participants who were interested in the study | 10 weeks | 
| number of potential participants who are eligible to enroll | number of people who passed the screening process via calls or emails | 10 weeks | 
| consent rate | number of participants who are willing to sign consent document at enrollment interview; number who pass the Montreal Cognitive Assessment and are willing to sign consent document | 10 weeks | 
| number of participants enrolled | number of people who enrolled into the study | 10 weeks | 
| number of dropouts due to stated distress from or dislike of either intervention experience (as opposed to someone needing to withdraw due to a family emergency or illness) | participant self-report of what made the intervention challenging - why they were unable or unwilling to complete the course | 8 weeks | 
| - number of minutes of homework practice each week | totaled from daily numbers reported by participant | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in symptom severity | measured by the Incontinence Severity Index | 16 weeks, 6 months | 
| change in symptom bother | measured by the Overactive Bladder questionnaire, short form | 16 weeks, 6 months | 
| change in perceived stress | measured by the Perceived Stress Scale | 16 weeks, 6 months | 
| change in perceived self-efficacy | measured by the Geriatric Self Efficacy Index for Urinary Incontinence | 16 weeks, 6 months | 
| self report of rate and trajectory of change in participant impression of improvement | measured by the Patient Global Impression of Improvement | 16 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary urge incontinence, urinary incontinence, older adult women, older adults, mindfulness-based stress reduction, health enhancement program, feasibility, randomized controlled trial, complementary, integrative, therapies