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

2019年2月11日 更新者:Katarina Felsted、University of Utah

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Utah
      • Salt Lake City、Utah、美国、84112
        • University of Utah

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 至 105年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Mindfulness-Based Stress Reduction
8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor
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
有源比较器:Health Enhancement Program
8 week manualized, standardized health enhancement program, taught by a certified health education specialist
This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of potential participants contacted
大体时间:10 weeks
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
大体时间:12 weeks
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
大体时间:44 weeks
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?"
大体时间:8 weeks
data coded from two participants' responses after each class in each arm
8 weeks
number of participants who completed each week's homework practice
大体时间:8 weeks
participants mark on homework practice log and submit weekly
8 weeks
number of participants recruited for enrollment
大体时间:10 weeks
potential participants who were interested in the study
10 weeks
number of potential participants who are eligible to enroll
大体时间:10 weeks
number of people who passed the screening process via calls or emails
10 weeks
consent rate
大体时间:10 weeks
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
大体时间:10 weeks
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)
大体时间:8 weeks
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
大体时间:8 weeks
totaled from daily numbers reported by participant
8 weeks

次要结果测量

结果测量
措施说明
大体时间
change in symptom severity
大体时间:16 weeks, 6 months
measured by the Incontinence Severity Index
16 weeks, 6 months
change in symptom bother
大体时间:16 weeks, 6 months
measured by the Overactive Bladder questionnaire, short form
16 weeks, 6 months
change in perceived stress
大体时间:16 weeks, 6 months
measured by the Perceived Stress Scale
16 weeks, 6 months
change in perceived self-efficacy
大体时间:16 weeks, 6 months
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
大体时间:16 weeks, 6 months
measured by the Patient Global Impression of Improvement
16 weeks, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Katarina F Felsted, MS、University of Utah

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月3日

初级完成 (实际的)

2018年4月12日

研究完成 (实际的)

2018年4月12日

研究注册日期

首次提交

2017年4月27日

首先提交符合 QC 标准的

2017年6月1日

首次发布 (实际的)

2017年6月6日

研究记录更新

最后更新发布 (实际的)

2019年2月15日

上次提交的符合 QC 标准的更新

2019年2月11日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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