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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

25

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Utah
      • Salt Lake City、Utah、アメリカ、84112
        • University of Utah

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

55年~105年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of potential participants contacted
時間枠: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
時間枠: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
時間枠: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?"
時間枠: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
時間枠:8 weeks
participants mark on homework practice log and submit weekly
8 weeks
number of participants recruited for enrollment
時間枠:10 weeks
potential participants who were interested in the study
10 weeks
number of potential participants who are eligible to enroll
時間枠:10 weeks
number of people who passed the screening process via calls or emails
10 weeks
consent rate
時間枠: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
時間枠: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)
時間枠: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
時間枠:8 weeks
totaled from daily numbers reported by participant
8 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
change in symptom severity
時間枠:16 weeks, 6 months
measured by the Incontinence Severity Index
16 weeks, 6 months
change in symptom bother
時間枠:16 weeks, 6 months
measured by the Overactive Bladder questionnaire, short form
16 weeks, 6 months
change in perceived stress
時間枠:16 weeks, 6 months
measured by the Perceived Stress Scale
16 weeks, 6 months
change in perceived self-efficacy
時間枠: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
時間枠:16 weeks, 6 months
measured by the Patient Global Impression of Improvement
16 weeks, 6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Katarina F Felsted, MS、University of Utah

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年2月3日

一次修了 (実際)

2018年4月12日

研究の完了 (実際)

2018年4月12日

試験登録日

最初に提出

2017年4月27日

QC基準を満たした最初の提出物

2017年6月1日

最初の投稿 (実際)

2017年6月6日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月15日

QC基準を満たした最後の更新が送信されました

2019年2月11日

最終確認日

2019年2月1日

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