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

Completed · Not applicable

Conditions studied: Urinary Incontinence, Urge, Urinary Incontinence in Old Age

In brief

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.

Key facts

Study ID: NCT03176901
Run by: University of Utah
People needed: 25
Starts: 2017-02-03
Expected to finish: 2018-04-12
Last updated by the study team: 2019-02-15

Who can join

Age: 55 and older, up to 105. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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