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

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.

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