Comparing Approaches to Treat Older Adult Women's Urge Incontinence: Pilot Feasibility and Randomized Controlled Trial
Condition: Urinary Incontinence, Urge; Urinary Incontinence in Old Age
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional

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.
    

Intervention name(s): Mindfulness-Based Stress Reduction; Health Enhancement Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two armed study with intervention and comparison groups running parallel to one another
Masking: Single (Participant)
Primary purpose: Other
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