NCT03176901

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 55 Years – 105 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Incontinence, Urge
• Urinary Incontinence in Old Age

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Stress Reduction	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
BEHAVIORAL	Health Enhancement Program	This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.

Timeline

• Start date: 2017-02-03
• Primary completion: 2018-04-12
• Completion: 2018-04-12
• First posted: 2017-06-06
• Last updated: 2019-02-15

Locations

1 site across 1 country: United States