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

Primary Purpose

Urinary Incontinence, Urge, Urinary Incontinence in Old Age

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Health Enhancement Program
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Incontinence, Urge focused on measuring urinary urge incontinence, urinary incontinence, older adult women, older adults, mindfulness-based stress reduction, health enhancement program, feasibility, randomized controlled trial, complementary, integrative, therapies

Eligibility Criteria

55 Years - 105 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Health Enhancement Program

Arm Description

8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor

8 week manualized, standardized health enhancement program, taught by a certified health education specialist

Outcomes

Primary Outcome Measures

Number of potential participants contacted
number of people who contacted PI during recruitment process, including the place they heard about the study
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
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
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
number of participants who completed each week's homework practice
participants mark on homework practice log and submit weekly
number of participants recruited for enrollment
potential participants who were interested in the study
number of potential participants who are eligible to enroll
number of people who passed the screening process via calls or emails
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
number of participants enrolled
number of people who enrolled into the study
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
- number of minutes of homework practice each week
totaled from daily numbers reported by participant

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2017
Last Updated
February 11, 2019
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03176901
Brief Title
Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial
Acronym
SHUW
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge, Urinary Incontinence in Old Age
Keywords
urinary urge incontinence, urinary incontinence, older adult women, older adults, mindfulness-based stress reduction, health enhancement program, feasibility, randomized controlled trial, complementary, integrative, therapies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two armed study with intervention and comparison groups running parallel to one another
Masking
Participant
Masking Description
This is a blinded, randomized controlled trial. Participants are blinded to condition.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor
Arm Title
Health Enhancement Program
Arm Type
Active Comparator
Arm Description
8 week manualized, standardized health enhancement program, taught by a certified health education specialist
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health Enhancement Program
Intervention Description
This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.
Primary Outcome Measure Information:
Title
Number of potential participants contacted
Description
number of people who contacted PI during recruitment process, including the place they heard about the study
Time Frame
10 weeks
Title
number of enrolled participants completing the study
Description
number of participants who attended at least five of nine classes number of excused absences number of unexcused absences
Time Frame
12 weeks
Title
percentage of course content delivered during intervention
Description
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
Time Frame
44 weeks
Title
positive or negative coded responses to the question "How did it go today?"
Description
data coded from two participants' responses after each class in each arm
Time Frame
8 weeks
Title
number of participants who completed each week's homework practice
Description
participants mark on homework practice log and submit weekly
Time Frame
8 weeks
Title
number of participants recruited for enrollment
Description
potential participants who were interested in the study
Time Frame
10 weeks
Title
number of potential participants who are eligible to enroll
Description
number of people who passed the screening process via calls or emails
Time Frame
10 weeks
Title
consent rate
Description
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
Time Frame
10 weeks
Title
number of participants enrolled
Description
number of people who enrolled into the study
Time Frame
10 weeks
Title
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)
Description
participant self-report of what made the intervention challenging - why they were unable or unwilling to complete the course
Time Frame
8 weeks
Title
- number of minutes of homework practice each week
Description
totaled from daily numbers reported by participant
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change in symptom severity
Description
measured by the Incontinence Severity Index
Time Frame
16 weeks, 6 months
Title
change in symptom bother
Description
measured by the Overactive Bladder questionnaire, short form
Time Frame
16 weeks, 6 months
Title
change in perceived stress
Description
measured by the Perceived Stress Scale
Time Frame
16 weeks, 6 months
Title
change in perceived self-efficacy
Description
measured by the Geriatric Self Efficacy Index for Urinary Incontinence
Time Frame
16 weeks, 6 months
Title
self report of rate and trajectory of change in participant impression of improvement
Description
measured by the Patient Global Impression of Improvement
Time Frame
16 weeks, 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
participants must self-identify as female to participate
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina F Felsted, MS
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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